Clindamycin Phosphate

ANDA 62943, held by Almaject. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 62943 (Clindamycin Phosphate), held by Almaject, was first approved by FDA on Sep 29, 1988, with 17 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1988
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Sep 29, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clindamycin PhosphateEQ 150MG BASE/ML · injectable;injection	Clindamycin Phosphate	Discontinued

All 18 submissions, including labeling and manufacturing supplements


May 28, 2026	Supplement 32Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 31Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 30Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 29Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 27Labeling · Standard review	Approved	None posted
Jan 18, 2013	Supplement 24Labeling · Standard review	Approved	None posted
Oct 10, 2008	Supplement 20Labeling	Approved	None posted
Aug 12, 2005	Supplement 15Labeling	Approved	None posted
Apr 12, 2004	Supplement 13Labeling	Approved	None posted
Jan 23, 2001	Supplement 9Manufacturing	Approved	None posted
Oct 26, 2000	Supplement 8Labeling	Approved	None posted
Aug 3, 1998	Supplement 7Manufacturing	Approved	None posted
Feb 23, 1994	Supplement 6Manufacturing	Approved	None posted
Feb 9, 1994	Supplement 5Labeling	Approved	None posted
Oct 22, 1991	Supplement 3Labeling	Approved	None posted
Oct 22, 1991	Supplement 2Labeling	Approved	None posted
Oct 18, 1988	Supplement 1Manufacturing	Approved	None posted
Sep 29, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 62943
Drugs@FDA: Overview at FDA
Company: Almaject, 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