Clindamycin Phosphate

ANDA 62811, held by G And W Labs Inc. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 62811 (Clindamycin Phosphate), held by G And W Labs Inc, was first approved by FDA on Sep 1, 1988, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 1, 1988
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Sep 1, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clindamycin PhosphateEQ 1% BASE · solution;topical	Clindamycin Phosphate	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Jun 1, 2016	Supplement 18Labeling · Standard review	Approved	None posted
Jun 1, 2016	Supplement 19Labeling · Standard review	Approved	None posted
Jun 1, 2016	Supplement 20Labeling · Standard review	Approved	None posted
Nov 14, 2014	Supplement 17Manufacturing	Approved	None posted
Nov 20, 2002	Supplement 10Manufacturing	Approved	None posted
Feb 8, 2001	Supplement 8Manufacturing	Approved	None posted
Jan 22, 2001	Supplement 6Manufacturing	Approved	None posted
Jan 22, 2001	Supplement 7Manufacturing	Approved	None posted
Jan 17, 2001	Supplement 9Manufacturing	Approved	None posted
Oct 3, 2000	Supplement 5Manufacturing	Approved	None posted
Nov 12, 1997	Supplement 4Manufacturing	Approved	None posted
Sep 23, 1996	Supplement 2Manufacturing	Approved	None posted
Jun 23, 1994	Supplement 1Manufacturing	Approved	None posted
Sep 1, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 62811
Drugs@FDA: Overview at FDA
Company: G & W Laboratories

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