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Wockhardt Limited, et al.; Withdrawal of Approval of 28 Abbreviated New Drug Applications

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 28 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of March 16, 2020.

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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.

End Further Info End Preamble Start Supplemental Information

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.DrugApplicant
ANDA 040732Phenytoin Sodium Capsules, 100 milligrams (mg) (Extended)Wockhardt Limited, c/o Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053.
ANDA 065230Ceftriaxone for Injection, Equivalent to (EQ) 250 mg base/vial; EQ 500 mg base/vial; EQ 1 gram (g) base/vial; EQ 2 g base/vialHospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
ANDA 065231Ceftriaxone for Injection, EQ 1 g base/vial; EQ 2 g base/vial Piggy BackDo.
ANDA 065290Cefotaxime Sodium for Injection, EQ 500 mg base/vial; EQ 1 g base/vial; EQ 2 g base/vialDo.
ANDA 065292Cefotaxime Sodium for Injection, EQ 10 g base/vial Pharmacy Bulk PackageDo.
ANDA 065293Cefotaxime Sodium for Injection, EQ 1 g base/vial; EQ 2 g base/vialDo.
ANDA 065312Cefoxitin for Injection, EQ 10 g base/vial Pharmacy Bulk PackageDo.
ANDA 065313Cefoxitin for Injection, EQ 1 g base/vial; EQ 2 g base/vialDo.
ANDA 065369Cefepime Hydrochloride (HCl) for Injection, EQ 500 mg base/vial; EQ 1 g base/vial; EQ 2 g base/vialDo.
ANDA 065483Cefuroxime Sodium for Injection, EQ 750 mg base/vial; EQ 1.5 g base/vialDo.
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ANDA 065484Cefuroxime Sodium for Injection, EQ 7.5 g base/vial Pharmacy Bulk PackageDo.
ANDA 065503Cefuroxime Sodium for Injection, EQ 1.5 g base/vialDo.
ANDA 075250Prednisolone Sodium Phosphate Oral Solution, EQ 15 mg base/5 milliliters (mL)Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
ANDA 075618Acetaminophen, Butalbital, Caffeine, and Codeine Phosphate Capsules, 325 mg, 50 mg, 40 mg, and 30 mgHikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 090375Ampicillin and Sulbactam for Injection, EQ 1 g base/vial and EQ 500 mg base/vial; EQ 2 g base/vial and EQ 1 g base/vialHospira, Inc.
ANDA 090646Ampicillin and Sulbactam for Injection, EQ 10 g base/vial and EQ 5 g base/vialDo.
ANDA 090653Ampicillin and Sulbactam for Injection, EQ 1 g base/vial and EQ 500 mg base/vial; EQ 2 g base/vial and EQ 1 g base/vialDo.
ANDA 090825Imipenem and Cilastatin for Injection, EQ 250 mg base/vial and 250 mg base/vial; EQ 500 mg base/vial and 500 mg/vialDo.
ANDA 090940Meropenem for Injection, 500 mg/vial, and 1 g/vialDo.
ANDA 091007Imipenem and Cilastatin for Injection, EQ 500 mg base/vial and 500 mg/vialDo.
ANDA 202268Cefepime HCl for Injection, EQ 1 g base/vial; EQ 2 g base/vialDo.
ANDA 202563Ceftriaxone for Injection, EQ 1 g base/vial; EQ 2 g base/vialDo.
ANDA 202864Ampicillin Sodium for Injection, EQ 250 mg base/vial; EQ 500 mg base/vial; EQ 1 g base/vial; EQ 2 g base/vialDo.
ANDA 202865Ampicillin Sodium for Injection, EQ 10 g base/vial Pharmacy Bulk PackageDo.
ANDA 203132Cefotaxime Sodium for Injection, EQ 1 g base/vial; EQ 2 g base/vialDo.
ANDA 204879Pyridoxine HCl Injection, 100 mg/mLMylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL 61103.
ANDA 206062Doxorubicin HCl for Injection, USP, 20 mg/vialHisun Pharmaceutical Hangzhou Co., LTD, 200 Crossing Blvd., 2nd Floor, Bridgewater, NJ 08807.
ANDA 206195Daunorubicin HCl for Injection, EQ 20 mg base/vialDo.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 16, 2020. Approval of each entire application is withdrawn, including any strengths or products 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 16, 2020 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.

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Dated: February 11, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2020-03025 Filed 2-13-20; 8:45 am]

BILLING CODE 4164-01-P