Document ID: FDA-2020-N-0601-0002
Agency: fda
Document Type: Notice
Title: Mylan Institutional LLC et al.; Withdrawal of Approval of 16
Abbreviated New Drug Applications; Correction
Posted Date: 2020-06-17T04:00Z

[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Page 36598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13070]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0601]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register on March 9, 2020. The document 
announced the withdrawal of approval (as of April 8, 2020) of 16 
abbreviated new drug applications (ANDAs) from multiple applicants. The 
document indicated that FDA was withdrawing approval of the following 
four ANDAs after receiving a withdrawal request from Lupin 
Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st 
Floor, Baltimore, MD 21202: ANDA 065488, Azithromycin Oral Suspension, 
Equivalent to (EQ) 100 milligrams (mg) base/5 milliliters (mL); EQ 200 
mg base/5 mL; ANDA 078410, Topiramate Tablets, 25 mg, 50 mg, 100 mg, 
and 200 mg; ANDA 090441, Imipramine Hydrochloride Tablets, 10 mg, 25 
mg, and 50 mg; and ANDA 200563, Ciprofloxacin Oral Suspension, 250 mg/5 
mL and 500 mg/5 mL. Before FDA withdrew the approval of these ANDAs, 
Lupin Pharmaceuticals, Inc., informed FDA that it did not want the 
approval of the ANDAs withdrawn. Because Lupin Pharmaceuticals, Inc., 
timely requested that approval of these ANDAs not be withdrawn, the 
approval of ANDAs 065488, 078410, 090441, and 200563 is still in 
effect.

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: In the Federal Register of Monday, March 9, 
2020 (85 FR 13661), in FR Doc. 2020-04691, the following correction is 
made:
    On page 13661, in the table, the entries for ANDAs 065488, 078410, 
090441, and 200563 are removed.

    Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13070 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P