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 In this section:

        Drug and Biologic Approval and IND Activity Reports

First Generic Drug Approvals

                        
                ANDA (Generic) Drug Approvals - Previous Years Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Drug and Biologic Approval and IND Activity Reports
          First Generic Drug ApprovalsDrug and Biologic Approval and IND Activity Reports First Generic Drug Approvals
  	
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    PrintEach year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.

“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.

*Note: Approved drugs are not always available on or after the listed approval date. Please contact the listed ANDA applicant for more information about a drug product’s availability.*

First-Time Generic Drug Approvals 2023*



ANDA Number
			Generic Name
			ANDA Applicant
			Brand Name
			ANDA Approval Date
			ANDA Indication+86
			206027
			Bromfenac Ophthalmic Solution, 0.07%
			Lupin Limited
			Prolensa (Bromfenac) Ophthalmic Solution
			11/22/2023
			For the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery85
			211097
			Teriparatide Injection USP, 600 mcg/2.4 mL (250 mcg/mL) Single-Patient-Use Prefilled Pens
			Apotex Inc.
			Forteo (Teriparatide) Injection
			11/16/2023
			For the rreatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy84
			208569
			Teriparatide Injection USP, 600 mcg/2.4 mL (250 mcg/mL) Single-Patient-Use Prefilled Pens
			Teva Pharmaceuticals USA, Inc.
			Forteo (Teriparatide) Injection
			11/16/2023
			For the rreatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy83
			213516
			Kit for the Preparation of Technetium Tc 99m Sulfur Colloid
			Jubilant DraxImage Inc
			Technetium TC 99M sulfur colloid kit
			11/9/2023
			Diagnostic radiopharmaceutical to assist in the localization of lymph nodes draining a primary tumor in adult patients with breast cancer; for evaluation of peritoneo-venous (LeVeen) shunt patency in adults; imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow; studies of esophageal transit and gastroesophageal reflux; detection of pulmonary aspiration of gastric contents82
			217713
			Pazopanib Tablets, 200 mg
			Apotex Inc
			Votrient (Pazopanib) Tablets
			10/19/2023
			For the treatment of adults with: advanced renal cell carcinoma; advanced soft tissue sarcoma who have received prior chemotherapy81
			217517
			Pazopanib Tablets, 200 mg
			Teva Pharmaceuticals, Inc.
			Votrient (Pazopanib) Tablets
			10/19/2023
			For the treatment of adults with: advanced renal cell carcinoma; advanced soft tissue sarcoma who have received prior chemotherapy80
			215837
			Pazopanib Tablets, 200 mg
			Sun Pharmaceutical Industries Limited
			Votrient (Pazopanib) Tablets
			10/19/2023
			For the treatment of adults with: advanced renal cell carcinoma; advanced soft tissue sarcoma who have received prior chemotherapy79
			217155
			Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL)
			Amneal EU, Limited
			Tranexamic Acid
			10/16/2023
			Antifibrinolytic indicated in patients with hemophilia for shortterm use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction78
			217134
			Iopamidol Injection USP, 41% Single-Dose Vial
			Hainan Poly Pharm. Co., Ltd.
			Isovue-200 (Iopamidol) Injection
			9/27/2023
			For angiography throughout the cardiovascular system; coronary arteriography and ventriculography; pediatric angiocardiography; selective visceral arteriography and aortography; peripheral venography; adult and pediatric intravenous excretory urography; intravenous adult and pediatric contrast enhancement of computed tomographic head and body imaging77
			216878
			Tofacitinib Oral Solution, 1 mg/mL
			Slayback Pharma LLC
			Xeljanz (Tofacitinib) Oral Solution
			9/25/2023
			For the treatment of Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Ulcerative Colitis; Polyarticular Course Juvenile Idiopathic Arthritis76
			215709
			Fluorescein Injection USP, 500 mg/5 mL (100 mg/mL) and 500 mg/2 mL (250 mg/mL) Single-Dose Vials
			Nexus Pharmaceuticals Inc.
			AK-FLUOR (Fluorescein) Injection
			9/25/2023
			Indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature75
			216081
			Gadobutrol Injection, 30 mmol/30 mL (1 mmol/mL) and 65 mmol/65 mL (1 mmol/mL) Imaging Bulk Package
			Jiangsu Hengrui Pharmaceuticals Co., Ltd.
			Gadavist (Gadobutro) Injection
			9/8/2023
			For use with magnetic resonance imaging to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system; to assess the presence and extent of malignant breast disease; to evaluate known or suspected supra-aortic or renal artery disease; to assess myocardial perfusion (stress, rest) and late gadolinium enhancement74
			217174
			Calcium Gluconate Injection, 1000 mg/50 mL and 2000 mg/100 mL (20 mg/mL) Single-Dose Containers
			Amneal EU, Limited
			Calcium Gluconate Injection
			9/5/2023
			For the treatment of acute symptomatic hypocalcemia73
			215572
			Spironolactone Oral Suspension, 25 mg/5 mL
			Amneal Pharmaceuticals LLC
			Carospir (Spironolactone) Oral Suspension
			9/5/2023
			For the treatment of NYHA Class III-IV heart failure and reduced ejection fraction ; to use as an add-on therapy for the treatment of hypertension, to lower blood pressure; for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions72
			215570
			Palbociclib Tablets, 75 mg, 100 mg, and 125 mg
			Synthon Pharmaceuticals, Inc.
			Ibrance (Palbociclib) Tablets
			8/28/2023
			For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, or fulvestrant in patients with disease progression following endocrine therapy71
			217442
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Ascent Pharmaceuticals, Inc
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults70
			217194
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Alkem Laboratories Limited
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults69
			217068
			Lisdexamfetamine Dimesylate Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg
			Ascent Pharmaceuticals Inc
			Vyvanse (Lisdexamfetamine Dimesylate ) Chewable Tablets
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults68
			216944
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Apotex Inc
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults67
			216266
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Prinston Pharmaceutical Inc.
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults66
			215802
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Lannett Company, Inc.
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults65
			215415
			Lisdexamfetamine Dimesylate Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg
			Teva Pharmaceuticals USA, Inc.
			Vyvanse (Lisdexamfetamine Dimesylate ) Chewable Tablets
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults64
			215330
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Rhodes Pharmaceuticals L.P.
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults63
			214547
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Norwich Pharmaceuticals, Inc.
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults62
			214484
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Sun Pharmaceutical Industries, Inc.
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults61
			214134
			Lisdexamfetamine Dimesylate Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg
			Sun Pharmaceutical Industries, Inc.
			Vyvanse (Lisdexamfetamine Dimesylate ) Chewable Tablets
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults60
			211840
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			SpecGx LLC
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults59
			202835
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Mylan Pharmaceuticals Inc.
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults58
			202830
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Amneal Pharmaceuticals LLC
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults57
			202827
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Hikma Pharmaceuticals USA Inc.
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults56
			202802
			Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
			Actavis Elizabeth LLC
			Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
			8/25/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults55
			215609
			Tretinoin Gel (Microsphere), 0.08%
			Encube Ethicals Private Limited
			Retin-A-Micro (Tretinoin) Gel Microsphere
			8/22/2023
			For the topical treatment of acne vulgaris54
			216541
			Calcium Gluconate Injection 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package
			B. Braun Medical, Inc.
			Calcium Gluconate in Sodium Chloride Injection
			8/21/2023
			For the treatment of acute symptomatic hypocalcemia53
			214640
			Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 0.1 mg/0.02 mg and 75 mg
			Xiromed Pharma Espana, S.L.
			Balcoltra (Levonorgestrel and Ethinyl Estradiol and Ferrous Bisglycinate) Tablets
			8/16/2023
			For use by females of reproductive potential to prevent pregnancy52
			215266
			Halobetasol Propionate Topical Foam, 0.05%
			Padagis Israel Pharmaceuticals Ltd.
			Lexette (Halobetasol Propionate) Topical Foam
			8/11/2023
			For the topical treatment of plaque psoriasis in patients twelve (12) years of age and older51
			215081
			Lifitegrast Ophthalmic Solution, 5%
			Micro Labs Limited
			Xiidra (Lifitegrast) Ophthalmic Solution
			8/4/2023
			For the treatment of the signs and symptoms of dry eye disease50
			206081
			Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 2.5 mg/1,000 mg, and 5 mg/1,000 mg
			Sun Pharmaceutical Industries Limited
			Kombiglyze XR (Saxagliptin and Metformin Hydrochloride) Extended-Release Tablets
			7/31/2023
			As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate49
			206078
			Saxagliptin Tablets, 2.5 mg and 5 mg
			Sun Pharmaceutical Industries Limited
			Onglyza (Saxagliptin) Tablets
			7/31/2023
			As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus48
			205994
			Saxagliptin Tablets, 2.5 mg and 5 mg
			Glenmark Pharmaceuticals Limited
			Onglyza (Saxagliptin) Tablets
			7/31/2023
			As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus47
			205981
			Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 2.5 mg/1,000 mg, and 5 mg/1,000 mg
			Mylan Pharmaceuticals Inc.
			Kombiglyze XR (Saxagliptin and Metformin Hydrochloride) Extended-Release Tablets
			7/31/2023
			As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate46
			205980
			Saxagliptin Tablets, 2.5 mg and 5 mg
			Mylan Pharmaceuticals Inc.
			Onglyza (Saxagliptin) Tablets
			7/31/2023
			As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus45
			205972
			Saxagliptin Tablets, 2.5 mg and 5 mg
			Aurobindo Pharma Limited
			Onglyza (Saxagliptin) Tablets
			7/31/2023
			As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus44
			205941
			Saxagliptin Tablets, 2.5 mg and 5 mg
			Amneal Pharmaceuticals of NY, LLC
			Onglyza (Saxagliptin) Tablets
			7/31/2023
			As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus43
			208980
			Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
			Zydus Pharmaceuticals (USA) Inc.
			Mozobil (Plerixafor) Injection
			7/24/2023
			In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma42
			215698
			Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
			Kindos Pharmaceuticals Co., Ltd.
			Mozobil (Plerixafor) Injection
			7/24/2023
			In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma41
			215334
			Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
			Amneal EU, Limited
			Mozobil (Plerixafor) Injection
			7/24/2023
			In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma40
			213672
			Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
			Eugia Pharma Specialities Limited
			Mozobil (Plerixafor) Injection
			7/24/2023
			In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma39
			211901
			Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
			MSN Laboratories Private Limited
			Mozobil (Plerixafor) Injection
			7/24/2023
			In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma38
			205197
			Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
			Teva Pharmaceuticals USA, Inc.
			Mozobil (Plerixafor) Injection
			7/24/2023
			In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma37
			205182
			Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
			Dr. Reddy's Laboratories Limited
			Mozobil (Plerixafor) Injection
			7/24/2023
			In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma36
			215893
			Ponatinib Tablets, 15 mg and 45 mg
			Apotex Inc.
			Iclusig (Ponatinib) Tablets
			7/14/2023
			For the treatment of adult patients with Chronic phase chronic myeloid leukemia (CML); accelerated phase or blast phase CML or Philadelphia chromosome positive acute lymphoblastic leukemia ; T315I-positive CML or T315I-positive Ph+ ALL35
			216947
			Ertugliflozin Tablets, 5 mg and 15 mg
			Aurobindo Pharma Limited
			Steglatro (Ertugliflozin) Tablets
			7/13/2023
			As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus34
			213369
			Oxcarbazepine Extended-Release Tablets, 150 mg, 300 mg, and 600 mg
			Apotex Inc.
			Oxtellar XR (Oxcarbazepine) Extended-Release Tablets
			7/13/2023
			For the treatment of partial-onset seizures in patients 6 years of age and older33
			213195
			Naltrexone for Extended-Release Injectable Suspension, 380 mg/vial, Single-Dose Vial
			Teva Pharmaceuticals USA, Inc.
			Vivitrol (Naltrexone) for Extended-Release Injectable Suspension
			7/6/2023
			For the prevention of relapse to opioid dependence, following opioid detoxification32
			210659
			Alcaftadine Ophthalmic Solution, 0.25% (OTC)
			Eugia Pharma Specialities Limited
			Lastacaft (Alcaftadine) Ophthalmic Solution
			6/23/2023
			Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander31
			209253
			Amphetamine Extended-Release Orally Disintegrating Tablets, 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg
			Actavis Laboratories FL, Inc.
			Adzenys XR-ODT (Amphetamine) Extended-Release Orally Disintegrating Tablets
			6/22/2023
			For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older30
			211287
			Tiotropium Bromide Inhalation Powder, 18 mcg/capsule
			Lupin Inc
			Spiriva HandiHaler (Tiotropium Bromide) Inhalation Powder
			6/20/2023
			For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema29
			215902
			Safinamide Tablets, 50 mg and 100 mg
			Aurobindo Pharma Limited
			Xadago (Safinamide) Tablets
			6/14/2023
			Adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes28
			215035
			Amlodipine Benzoate Oral Suspension, 1 mg/mL (150 mL)
			Amneal Pharmaceuticals LLC
			Katerzia (Amlodipine Benzoate) Oral Suspension
			6/13/2023
			For the treatment of hypertension and coronary artery disease27
			214008
			Trifluridine and Tipiracil Tablets, 15 mg/6.14 mg and 20 mg/8.19 mg
			Natco Pharma Limited
			Lonsurf (Trifluridine and Tipiracil) Tablets
			6/13/2023
			For the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy26
			214337
			Sugammadex Injection, 200 mg/2 mL (100 mg/mL), 500 mg/5 mL (100 mg/mL) Single-Dose Vial
			Aspiro Pharma Limited
			Bridion (Sugammadex) Injection
			6/9/2023
			Reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery25
			217252
			Baclofen Oral Suspension, 25 mg/5 mL (5 mg/mL)
			Slayback Pharma LLC
			Fleqsuvy (Baclofen) Oral Suspension
			6/8/2023
			Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity and some value in patients with spinal cord injuries and other spinal cord diseases24
			215017
			Obeticholic Acid Tablets, 5 mg and 10 mg
			MSN Laboratories Private Limited
			Ocaliva (Obeticholic Acid ) Tablets
			5/30/2023
			For the treatment of adult patients with primary biliary cholangitis23
			214980
			Obeticholic Acid Tablets, 5 mg and 10 mg
			Lupin Limited
			Ocaliva (Obeticholic Acid ) Tablets
			5/30/2023
			For the treatment of adult patients with primary biliary cholangitis22
			214862
			Obeticholic Acid Tablets, 5 mg and 10 mg
			Apotex Inc.
			Ocaliva (Obeticholic Acid ) Tablets
			5/30/2023
			For the treatment of adult patients with primary biliary cholangitis21
			091076
			Diazepam Rectal Gel Rectal Delivery System, 10 mg and 20 mg
			Novel Laboratories, Inc.
			Diastat AcuDial (Diazepam) Rectal Gel Rectal Delivery System
			5/30/2023
			For the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity20
			216435
			Edetate Calcium Disodium Injection, USP, 1,000 mg/5 mL (200 mg/mL) Single-Dose Vial
			Casper Pharma LLC
			Calcium Disodium Versenate Injection
			5/3/2023
			For the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults19
			217213
			Methsuximide Capsules USP, 300 mg
			Novitium Pharma LLC
			Celontin (Methsuximide) Capsules
			5/1/2023
			For the control of absence (petit mal) seizures that are refractory to other drugs18
			213267
			Thalidomide Capsules USP, 50 mg, 100 mg, 150 mg, 200 mg
			Natco Pharma Limited
			Thalomid (Thalidomide) Capsules
			4/27/2023
			For the treatment of patients with newly diagnosed multiple myeloma; for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL); as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence17
			216159
			Midazolam in 0.9% Sodium Chloride Injection, 50 mg/50 mL (1mg/mL) and 100 mg/100 mL (1 mg/mL) Single-Dose Bags
			Hikma Pharmaceuticals USA Inc.
			Midazolam in 0.9% Sodium Chloride Injection
			4/17/2023
			Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting16
			204379
			Estradiol Transdermal System USP, 0.014 mg/day
			Zydus Noveltech, Inc
			Menostar (Estradiol) Transdermal System
			4/17/2023
			For the prevention of postmenopausal osteoporosis15
			215933
			Loteprednol Etabonate Ophthalmic Suspension, 0.2%
			Akorn Operating Company LLC
			Alrex (Loteprednol Etabonate) Ophthalmic Suspension
			4/12/2023
			For the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis14
			215328
			Budesonide Rectal Foam, 2 mg/dose
			Padagis Israel Pharmaceuticals Ltd.
			Uceris (Budesonide) Rectal Foam
			4/12/2023
			For the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge13
			214226
			Tenofovir Alafenamide Tablets, 25 mg
			Lupin Limited
			Vemlidy (Tenofovir Alafenamide) Tablets
			3/30/203
			For the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease12
			214688
			Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064%
			Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited
			Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam
			3/21/2023
			For the topical treatment of plaque psoriasis in patients 12 years and older11
			209738
			Tofacitinib Tablets, 5 mg and 10 mg
			Micro Labs Limited
			Xeljanz (Tofacitinib) Tablets
			3/13/2023
			For the treatment of adult patients with moderately to severely active rheumatoid arthritis; active psoriatic arthritis; moderately to severely active ulcerative colitis10
			205770
			Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules, 140 mg/125 mg/125 mg
			Par Pharmaceutical, Inc.
			Pylera (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride) Capsules
			3/6/2023
			For the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori9
			214836
			Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)
			L. Perrigo Company
			Advil Dual Action with Acetaminophen (Acetaminophen and Ibuprofen) Tablets (OTC)
			2/28/2023
			Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis8
			217219
			Tiopronin Delayed-Release Tablets, 100 mg and 300 mg
			Par Pharmaceutical, Inc.
			Thiola (Tiopronin) EC Tablets
			2/24/2023
			For the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone7
			215408
			Doxepin Hydrochloride Cream, 5%
			Teva Pharmaceuticals Development, Inc.
			Zonalon (Doxepin Hydrochloride) Cream
			2/17/2023
			For the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus6
			216167
			Topiramate Extended-Release Capsules, 200 mg
			Zydus Pharmaceuticals (USA) Inc.
			Trokendi XR (Topiramate) Extended-Release Capsules
			2/9/2023
			Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older; preventive treatment of migraine in patients 12 years of age and older5
			213947
			Tirofiban Hydrochloride Injection, 5 mg/100 mL (50 mcg/mL), Single-Dose Containers
			Nexus Pharmaceuticals, Inc.
			Aggrastat (Tirofiban Hydrochloride) Injection
			2/7/2023
			To reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome4
			213073
			Cysteine Hydrochloride Injection USP, 725 mg/10 mL (72.5 mg/mL)
			Nivagen Pharmaceuticals, Inc.
			Cysteine Hydrochloride Injection
			1/26/2023
			For use as an additive to amino acids solutions to meet nutritional requirements of newborn infants requiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN3
			211452
			Morphine Sulfate Injection USP, 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, 15 mg/mL
			Hikma Pharmaceuticals International Limited
			Morphine Sulfate Injection
			1/12/2023
			For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate2
			216496
			Phenylephrine Hydrochloride Ophthalmic Solution USP, 10 %
			Mankind Pharma Limited
			Phenylephrine Hydrochloride Ophthalmic Solution
			1/11/2023
			For the purpose of dilating the pupils1
			215908
			Nitisinone Capsules, 2 mg, 5 mg, 10 mg, and 20 mg
			Torrent Pharma Inc.
			Orfadin (Nitisinone) Capsules
			1/9/2023
			For the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine

Note: As outlined in theProposed Criteria for First Generic Submissions for Purposes of ANDA, certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.
*This table reflects current data as of the date the listed approval was made. Post-approval status changes, including approved use or indications, approval date, approval status, etc. are not reflected here. To view the most current information on any ANDA listed, please check its Drugs@FDA listing.
+Due to space limitations, abbreviated indications are listed. For full indication information, please check Drugs@FDA.

To view all Generic Drug Approvals and Tentative Approvals, use the "Drug Approval Reports by Month" feature on Drugs@FDA and select "Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals or "Tentative Approvals by Month" for Tentative Approvals. The database is updated daily.

                                                                                  Content current as of:
      01/19/2024
                  
                   
Regulated Product(s)
		 Drugs
			  			     			  						              
			
			
			
			
						  Generic DrugsFirst Generic Drug Approvals                
                          

                        ANDA (Generic) Drug Approvals - Previous Years
 
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