Clindamycin Phosphate

ANDA 65254, held by Fougera Pharms. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 65254 (Clindamycin Phosphate), held by Fougera Pharms, was first approved by FDA on Feb 14, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 14, 2006
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Feb 14, 2006	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Mar 19, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Mar 19, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Feb 14, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 65254
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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