Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices 5827 

will take respondents, collectively, 

1,080 hours to gather, copy, and submit 

brief statements about the product, a 

description of the details of the 

anticipated meeting, and data and 

information, including identifying prior 

FDA submissions for the product or 

relevant versions of the product, that 

generally would already have been 

generated for the planned research and/ 

or product development. 

The total number of burden hours for 

this collection of information is 

estimated to be 1,680 hours (600 hours 

to prepare and submit meeting requests 

and 1,080 hours to prepare and submit 

information packages). Our estimated 

burden for the information collection 

reflects an overall decrease of 644 hours. 

We attribute this adjustment to a 

decrease in the number of submissions 

we received over the last few years and 

our projections for the next 3 years. 

Dated: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02055 Filed 2–1–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0079] 

Hikma Pharmaceuticals USA, Inc., et 

al.; Withdrawal of Approval of 29 New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 29 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applications be withdrawn. 

DATES: Approval is withdrawn as of 

March 4, 2022. 

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 the table 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. 

Application No. Drug Applicant 

NDA 006134 ........................ Dolophine (methadone hydrochloride (HCl)) Tablets, 5 

milligrams (mg), and 10 mg.

Hikma Pharmaceuticals USA, Inc., 1809 Wilson Rd., 

Columbus, OH 43228. 

Dolophine (methadone HCl) Syrup, 10 mg/30 milliliter 

(mL).

NDA 006882 ........................ Phisohex (hexachlorophene) Emulsion, 3% ................... Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807. 

NDA 009818 ........................ Kemadrin (procyclidine HCl) Tablets, 2 mg, and 5 mg .. Monarch Pharmaceuticals, LLC, c/o Pfizer, Inc., 235 

East 42nd St., New York, NY 10017. 

NDA 012301 ........................ Librium (chlordiazepoxide HCl), Injection, 100 mg/ampule.Bausch Health US, LLC, 400 Somerset Corporate 

Blvd., Bridgewater, NJ 08807. 

NDA 013416 ........................ Norgesic (orphenadrine citrate, aspirin, and caffeine) 

Tablets, 25 mg/385 mg/30 mg.

Bausch Health US, LLC. 

Norgesic Forte (orphenadrine citrate, aspirin, and caffeine) Tablets, 50 mg/770 mg/60 mg.

NDA 014228 ........................ Spandin (aspirin and sodium salicylate) Time-released 

Tablets, 7.5 grains/2.5 grains.

Abbott Healthcare Pvt. Ltd., c/o G&L Scientific, Independence Blvd., 4th Floor, Warren, NJ 07059. 

NDA 016194 ........................ Talwin (pentazocine lactate) Injection, equivalent to 

(EQ) 30 mg base/mL.

Hospira Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. 

NDA 016418 ........................ Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40 

mg, 60 mg, 80 mg, and 90 mg.

Wyeth Pharmaceuticals LLC, 235 E. 42nd St., New 

York, NY 10017. 

NDA 016704 ........................ Resectisol (mannitol) Irrigation Solution, 5 grams (g)/ 

100 mL.

B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 

18109. 

NDA 016762 ........................ Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40 

mg, 60 mg, and 80 mg.

Wyeth Pharmaceuticals LLC. 

NDA 016954 ........................ Micronor (norethindrone) Tablets, 0.35 mg .................... Janssen Pharmaceuticals, Inc., 1125 TrentonHarbourton Rd., Titusville, NJ 08560. 

NDA 017013 ........................ Sodium Chloride Injection, 20 g/100 mL ........................ Abbott Healthcare Pvt. Ltd., c/o G&L Scientific. 

NDA 017683 ........................ Inderal (propranolol HCL) Tablets, 10 mg, 20 mg, 40 

mg, 60 mg, and 80 mg.

Wyeth Pharmaceuticals LLC. 

NDA 018423 ........................ Hibiclens (chlorhexidine gluconate) Sponge, 4% ........... Mo ̈lnlycke Health Care, 5445 Triangle Pkwy., Suite 

400, Peachtree Corners, GA 30092. 

NDA 018703 ........................ Zantac (ranitidine HCl) Tablets, EQ 150 mg base, and 

EQ 300 mg base.

GlaxoSmithKline Intellectual Property Ltd. England, c/o 

GlaxoSmithKline, 5 Crescent Dr., Philadelphia, PA 

19112. 

NDA 019387 ........................ Profenal (suprofen) Ophthalmic Solution, 1% ................ Alcon Laboratories, Inc., 6201 South Freeway, Fort 

Worth, TX 76134–2099. 

NDA 019530 ........................ Ucephan (sodium benzoate and sodium phenylacetate) 

Solution, 100 mg/mL; 100 mg/mL.

B. Braun Medical Inc. 

NDA 019675 ........................ Zantac (ranitidine HCl) Syrup, EQ 15 mg base/mL ........ GlaxoSmithKline Intellectual Property Ltd. England, c/o 

GlaxoSmithKline. 

NDA 019814 ........................ Betagan (levobunolol HCl) Ophthalmic Solution, 0.25% Allergan, Inc. 

NDA 019927 ........................ Nizoral (ketoconazole) Shampoo, 2% ............................ Janssen Pharmaceuticals, Inc. 


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5828 Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices 

Application No. Drug Applicant 

NDA 020037 ........................ Voltaren (diclofenac sodium) Ophthalmic Solution, 0.1% Novartis Pharmaceuticals Corp., 1 Health Plaza, East 

Hanover, NJ 07936–1080. 

NDA 021169 ........................ Razadyne (galantamine hydrobromide) Tablets, EQ 4 

mg base, EQ 8 mg base, and EQ 12 mg base.

Janssen Research & Development, LLC, 1125 TrentonHarbourton Rd., Titusville, NJ 08560. 

NDA 021204 ........................ Starlix (nateglinide) Tablets, 60 mg, and 120 mg .......... Novartis Pharmaceuticals Corp. 

NDA 021406 ........................ Fortical (calcitonin-salmon recombinant) Nasal Spray, 

200 International Units/Spray.

Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., 

Maple Grove, MN 55369. 

NDA 021860 ........................ Sarafem (fluoxetine HCl) Tablets, EQ 10 mg base, EQ 

15 mg base, and EQ 20 mg base.

Allergan Pharmaceuticals International Ltd., c/o 

Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 

07940. 

NDA 202833 ........................ Picato (ingenol mebutate) Gel, 0.015%, and 0.05% ...... LEO Laboratories Ltd., c/o LEO Pharma Inc., 7 Giralda 

Farms, Madison, NJ 07940. 

NDA 202880 ........................ Zohydro ER (hydrocodone bitartrate) Extended-release 

Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 

50 mg.

Recro Gainesville LLC, 1300 Gould Dr., Gainesville, 

GA 30504. 

NDA 204683 ........................ Khedezla (desvenlafaxine) Extended-Release Tablets, 

50 mg, and 100 mg.

Osmotica Pharmaceutical US LLC, 400 Crossing Blvd., 

Bridgewater, NJ 08807. 

NDA 207916 ........................ Cetylev (acetylcysteine) Effervescent Tablets, 500 mg, 

and 2.5 g.

Arbor Pharmaceuticals, LLC, 6 Concourse Pkwy., Suite 

1800, Atlanta, GA 30328. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of March 4, 

2022. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in the table 

that are in inventory on March 4, 2022 

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 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02059 Filed 2–1–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0074] 

Watson Laboratories, Inc., et al.; 

Withdrawal of Approval of Eight 

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 eight 

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 

March 4, 2022. 

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, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described 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. 

Application No. Drug Applicant 

ANDA 075152 ........ Diclofenac Potassium Tablets, 50 milligrams (mg) ................ Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Bldg. A, Parsippany, NJ 07054. 

ANDA 091376 ........ Topotecan Hydrochloride (HCl) for Injection, Equivalent to 

(EQ) 4 mg base/vial.

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. 

ANDA 091471 ........ Efavirenz Tablets, 600 mg ..................................................... Mylan Pharmaceuticals Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505. 

ANDA 200463 ........ Itraconazole Capsules, 100 mg ............................................. Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504. 

ANDA 202395 ........ Ziprasidone HCl Capsules, EQ 20 mg base, EQ 40 mg 

base, EQ 60 mg base, and EQ 80 mg base.

Do. 

ANDA 203170 ........ Docetaxel Injection, 40 mg/milliliter ........................................ Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent, 

eVenus Pharmaceutical Laboratories Inc., 506 Carnegie 

Center, Suite 100, Princeton, NJ 08540. 

ANDA 203574 ........ Mesalamine Delayed Release Tablets, 1.2 grams ................ Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504. 

ANDA 208177 ........ Atazanavir Sulfate Capsules, EQ 150 mg base, EQ 200 mg 

base, and EQ 300 mg base.

Do. 


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