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Mylan Institutional LLC et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of April 8, 2020.

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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,

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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 040471Promethazine Hydrochloride (HCl) Injection, 25 milligrams (mg)/milliliters (mL)Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103.
ANDA 060286Penicillin G Procaine Injection, 300,000 units/mL and 600,000 units/mLPfizer, Inc., 235 East 42nd St., New York, NY 10017.
ANDA 065247Cefazolin Sodium for Injection, Equivalent to (EQ) 10 grams base/vialHospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
ANDA 065488Azithromycin Oral Suspension, EQ 100 mg base/5 mL; EQ 200 mg base/5 mLLupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202.
ANDA 076185Dimethyl Sulfoxide Intravesical Solution, 50%Mylan Institutional LLC.
ANDA 076428Milrinone Lactate Injection, EQ 1 mg base/mLDo.
ANDA 076488Mesna Injection, 100 mg/mLDo.
ANDA 078410Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mgLupin Pharmaceuticals, Inc.
ANDA 078957Stavudine Capsules, 15 mg, 20 mg, 30 mg, and 40 mgHetero USA, Inc., 1035 Centennial Ave., Piscataway, NJ 08854.
ANDA 090441Imipramine HCl Tablets, 10 mg, 25 mg, and 50 mgLupin Pharmaceuticals, Inc.
ANDA 200563Ciprofloxacin Oral Suspension, 250 mg/5 mL and 500 mg/5 mLDo.
ANDA 205657Chlorpheniramine Maleate, Hydrocodone Bitartrate, and Pseudoephedrine HCl Solution, 4 mg/5 mL; 5 mg/5 mL; and 60 mg/5 mLMayne Pharma Inc., 1240 Sugg Pkwy., Greenville, NC 27834.
ANDA 205658Hydrocodone Bitartrate and Pseudoephedrine HCl Oral Solution, 5 mg/5 mL; and 60 mg/5 mLDo.
ANDA 200624Metformin HCl, and Repaglinide Tablets, 500 mg/1 mg; 500 mg/2 mgLupin Pharmaceuticals, Inc.
ANDA 202384Omeprazole Delayed-Release Capsules, 40 mgDo.
ANDA 202532Clarithromycin Extended-Release Tablets, 500 mgDo.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 8, 2020. 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 April 8, 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: March 2, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2020-04691 Filed 3-6-20; 8:45 am]