Clindets

ANDA 64136, held by Perrigo Co. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 64136 (Clindets), held by Perrigo Co, was first approved by FDA on Sep 30, 1996, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1996
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Sep 30, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ClindetsEQ 1% BASE · swab;topical	Clindamycin Phosphate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Dec 9, 2003	Supplement 8Labeling	Approved	None posted
Nov 1, 2002	Supplement 5Labeling	Approved	None posted
Oct 17, 2002	Supplement 4Manufacturing	Approved	None posted
Jun 29, 2001	Supplement 3Manufacturing	Approved	None posted
Oct 22, 1999	Supplement 2Manufacturing	Approved	None posted
Jul 29, 1997	Supplement 1Manufacturing	Approved	None posted
Sep 30, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 64136
Drugs@FDA: Overview at FDA
Company: Perrigo

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters