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Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications

The Food and Drug Administration (FDA or the Agency) is withdrawing approval of 11 abbreviated new drug applications (ANDAs) from Dr. Reddy's Laboratories, Inc. The applicant no...

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Department of Health and Human Services

Food and Drug Administration

[Docket No. FDA-2023-N-3859]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or the Agency) is withdrawing approval of 11 abbreviated new drug applications (ANDAs) from Dr. Reddy's Laboratories, Inc. The applicant 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of November 3, 2023.

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 applicant listed in the table has informed FDA that these drug products are no longer marketed and has requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicant has also, by their request, waived the opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. ( printed page 68629)

Application No.	Drug	Applicant
ANDA 090177	Oxycodone and Acetaminophen Tablets, 3.25 milligrams (mg); 2.5 mg, 325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 mg, 500 mg; 7.5 mg, 650 mg; 10 mg	Dr. Reddy's Laboratories, Inc., U.S. Agent for Dr. Reddy's Laboratories SA, 107 College Rd. East, Princeton NJ 08540.
ANDA 091313	Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg	Do.
ANDA 091670	Oxycodone and Aspirin Tablets, 325 mg; 4.8355 mg	Do.
ANDA 203107	Oxycodone HCl Capsules, 5 mg	Do.
ANDA 203335	Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg; 50 mg; 40 mg; 30 mg	Do.
ANDA 203807	Clozapine Tablets, 25 mg, 50 mg, 100 mg, 200 mg	Do.
ANDA 204092	Oxycodone HCl Oral Solution 100 mg/5 milliliters	Do.
ANDA 205386	Morphine Sulfate Extended-Release Tablets, 15 mg, 30 mg, 60 mg, 100 mg	Do.
ANDA 206329	Fentanyl Citrate Tablets, Equivalent to (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, EQ 0.8 mg base	Do.
ANDA 206953	Buprenorphine HCl and Naloxone HCI Tablets, EQ 2 mg base, EQ 0.5 mg base; EQ 8 mg base, EQ 2 mg base	Do.
ANDA 207270	Morphine Sulfate Tablets, 15 mg, 30 mg	Do.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 3, 2023. 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 November 3, 2023 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: September 29, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2023-21992 Filed 10-3-23; 8:45 am]

BILLING CODE 4164-01-P

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

88 FR 68628

Web Citation

Suggested Web Citation

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“Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications,” thefederalregister.org (October 4, 2023), https://thefederalregister.org/documents/2023-21992/dr-reddy-s-laboratories-inc-withdrawal-of-approval-of-11-abbreviated-new-drug-applications.