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9. Montgomery, M.T., X.A. Conlan, A.G. 

Theakstone, et al. ‘‘Extraction and 

Determination of Morphine Present on 

the Surface of Australian Food Grade 

Poppy Seeds Using Acidic Potassium 

Permanganate Chemiluminescence 

Detection.’’ Food Analytical Methods, 

13(5):1159–1165, 2020. Available at 

https://doi.org/10.1007/s12161-020-

01729-z (accessed December 8, 2024). 

10. Lo, D. and T. Chua. ‘‘Poppy Seeds: 

Implications of Consumption.’’ 

Medicine, Science and the Law, 

32(4):296–302, 1992. Available at https:// 

doi.org/10.1177/002580249203200403 

(accessed December 8, 2024). 

11. Sproll, C., R.C. Perz, R. Buschmann, et al. 

‘‘Guidelines for Reduction of Morphine 

in Poppy Seed Intended for Food 

Purposes.’’ European Food Research and 

Technology, 226(1):307–310, 2007. 

Available at https://doi.org/10.1007/

s00217-006-0522-7 (accessed December. 

8, 2024). 

12. Shetge, S.A., M.P. Dzakovich, J.L. 

Cooperstone, et al. ‘‘Concentrations of 

the Opium Alkaloids Morphine, 

Codeine, and Thebaine in Poppy Seeds 

are Reduced After Thermal and Washing 

Treatments But Are Not Affected When 

Incorporated in a Model Baked Product.’’ 

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2024). 

Dated: January 8, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00757 Filed 1–14–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5964] 

Teva Pharmaceuticals USA, Inc., et al.; 

Withdrawal of Approval of 23 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 23 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

notified the Agency in writing that the 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

February 14, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 301– 

796–3471, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in table 1 have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 

Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) is without prejudice 

to refiling. 

TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN

Application No. Drug Applicant 

ANDA 040454 .... Promethazine Hydrochloride (HCl) injectable, 25 milligrams 

(mg)/milliliters (mL) and 50 mg/mL.

Teva Pharmaceuticals USA, Inc., 400 Interpace Parkway, 

Bldg. A, Parsippany, NJ 07054. 

ANDA 040593 .... Promethazine HCl injectable, 25 mg/mL and 50 mg/mL ......... Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540. 

ANDA 064042 .... Nystatin suspension, 100,000 units/mL ................................... PAI Holdings, LLC, dba Pharmaceutical Associates, Inc., and 

dba PAI Pharma, 1700 Perimeter Rd., Greenville, SC 

29605. 

ANDA 074811 .... Haloperidol Decanoate injectable, Equivalent to (EQ) 50 mg 

base/mL.

Hikma Pharmaceuticals USA Inc., 2 Esterbrook Lane, Cherry 

Hill, NJ 08003. 

ANDA 076061 .... Pergolide Mesylate tablet, EQ 0.05 mg base, EQ 0.25 mg 

base, and EQ 1 mg base.

Strides Pharma Inc., U.S. Agent for Strides Pharma Global 

Pte Ltd., 2 Tower Center Blvd., Suite 1102, East Brunswick, NJ 08816. 

ANDA 079075 .... Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, 

EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base.

Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Parkway, Bldg. A, Parsippany, NJ 07054. 

ANDA 079240 .... Sumatriptan Succinate injectable, EQ 6 mg base/0.5 mL (EQ 

12 mg base/mL) and EQ 4 mg base/0.5 mL (EQ 8 mg 

base/mL).

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, 

IL 60047. 

ANDA 084591 .... Promethazine HCl injectable, 25 mg/mL ................................. Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.). 

ANDA 090016 .... Irinotecan HCl injectable, 40 mg/2mL (20 mg/mL) and 100 

mg/5 mL (20 mg/mL).

Hisun Pharmaceuticals USA Inc., U.S. Agent for Hisun Pharmaceutical (Hangzhou) Co., Ltd., 200 Crossing Blvd., 2nd 

Floor, Bridgewater, NJ 08807. 

ANDA 200536 .... Ranitidine HCl tablet, EQ 150 mg base .................................. Strides Pharma Inc., U.S. Agent for Strides Pharma Global 

Pte Ltd. 

ANDA 201745 .... Ranitidine HCl tablet, EQ 75 mg base .................................... Do. 

ANDA 204991 .... Atorvastatin Calcium tablet, EQ 10 mg base, EQ 20 mg 

base, EQ 40 mg base, and EQ 80 mg base.

Lupin Pharmaceuticals, Inc., U.S. Agent for Lupin Ltd., 

Harborplace Tower, 111 South Calvert St., 21st Floor, Baltimore, MD 21202. 

ANDA 205512 .... Ranitidine HCl tablet, EQ 150 mg base and EQ 300 mg base Strides Pharma Inc., U.S. Agent for Strides Pharma Global 

Pte Ltd. 

ANDA 206155 .... Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 

20 mg.

RegCon Solutions, LLC, U.S. Agent for Indoco Remedies 

Ltd., 9920 Pacific Heights Blvd., Suite 250, San Diego, CA 

92121. 

ANDA 206204 .... Piperacillin and Tazobactam injectable, EQ 12 grams (g) 

base/vial; EQ 1.5 g base/vial.

Fresenius Kabi USA, LLC. 

ANDA 207338 .... Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, 

EQ 0.3 mg base, EQ 0.4 mg base, EQ 0.6 mg base, and 

EQ 0.8 mg base.

Actavis Laboratories FL, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA Inc.), 400 Interpace 

Parkway, Bldg. A, Parsippany, NJ 07054. 


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Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 3877 

TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN—Continued 

Application No. Drug Applicant 

ANDA 207919 .... Acyclovir Sodium injectable, EQ 50 mg base/mL ................... Dr. Reddy’s Laboratories Inc., 107 College Rd. East, Princeton, NJ 08540. 

ANDA 209325 .... Miglustat capsule, 100 mg ....................................................... Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 

201, Berlin, CT 06037. 

ANDA 209708 .... Mivacurium Chloride solution, EQ 10 mg base/5 mL (EQ 2 

mg base/mL) and EQ 20 mg base/10 mL (EQ 2 mg base/ 

mL).

Woodward Pharma Services, LLC, 47220 Cartier Dr., Suite 

A, Wixom, MI 48393. 

ANDA 211893 .... Ranitidine HCl capsule, EQ 150 mg base and EQ 300 mg 

base.

Appco Pharma LLC, 262 Old New Brunswick Rd., Suite M, 

N, B–1, F, Piscataway, NJ 08854. 

ANDA 214428 .... Niacin extended-release tablet, 500 mg and 1 g .................... Sciecure Pharma Inc., U.S. Agent for Beijing Sciecure Pharmaceutical Co., Ltd., 138 Glendale Ave., Edison, NJ 

08817. 

ANDA 215908 .... Nitisinone capsule, 2 mg, 5 mg, 10 mg, and 20 mg ............... Torrent Pharma Inc., 106 Allen Rd., Suite 305, Basking 

Ridge, NJ 07920. 

ANDA 217094 .... Fluphenazine HCl tablet, 1 mg, 2.5 mg, 5 mg, and 10 mg ..... Torrent Pharma Inc., U.S. Agent for Torrent Pharmaceuticals 

Ltd., 106 Allen Rd., Suite 305, Basking Ridge, NJ 07920. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of February 14, 

2025. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from table 1. 

Introduction or delivery for introduction 

into interstate commerce of products 

listed in table 1 without an approved 

new drug application or ANDA violates 

sections 505(a) and 301(d) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(a) and 331(d)). Drug products that 

are listed in table 1 that are in inventory 

on February 14, 2025 may continue to 

be dispensed until the inventories have 

been depleted or the drug products have 

reached their expiration dates or 

otherwise become violative, whichever 

occurs first. 

Dated: January 8, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00742 Filed 1–14–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5851] 

Teva Branded Pharmaceutical 

Products R&D, Inc., et al.; Withdrawal 

of Approval of 12 New Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 12 new drug 

applications (NDAs) from multiple 

applicants. The applicants notified the 

Agency in writing that the drug 

products were no longer marketed and 

requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

February 14, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in table 1 have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 

Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) is without prejudice 

to refiling. 

TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN

Application No. Drug Applicant 

NDA 009388 .......... Diamox IV (acetazolamide) Injectable, Equivalent to (EQ) 

500 milligrams (mg) base per vial.

Teva Branded Pharmaceutical Products R&D, Inc., 145 

Brandywine Parkway, West Chester, PA 19380. 

NDA 012836 .......... Persantine (dipyridamole) Tablets, 25mg, 50mg, and 75mg Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury 

Road, P.O. Box 368, Ridgefield, CT 06877. 

NDA 018817 .......... Calan (verapamil hydrochloride (HCl)) Tablets, 40 mg, 80 

mg, 120 mg, and 160 mg.

Pfizer Inc., 66 Hudson Boulevard East, New York, NY 

10001. 

NDA 021743 .......... Tarceva (erlotinib HCl) Tablets, EQ 25 mg base, EQ 100 

mg base, and EQ 150 mg base.

OSI Pharmaceuticals, LLC, 2375 Waterview Dr., Northbrook, IL 60062. 

NDA 021785 .......... Invirase (saquinavir mesylate) Tablets, EQ 500 mg base ..... Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way, 

South San Francisco, CA 94080. 

NDA 021937 .......... Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) Tablets, 600 mg/200 mg/300 mg.Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 

94404. 

NDA 022383 .......... Arcapta Neohaler (indacaterol maleate) Powder for Inhalation, EQ 75 micrograms base.Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936. 

NDA 204412 .......... Delzicol (mesalamine), Delayed-Release Capsules, 400 mg AbbVie Inc., 1 N. Waukegan Rd., North Chicago, IL 60064. 

NDA 210875 .......... Kynmobi (apomorphine HCl) Sublingual Film, 10 mg, 15 

mg, 20 mg, 25 mg, and 30 mg.

Sumitomo Pharma America, Inc., 84 Waterford Dr., Marlborough, MA 01752. 


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