Clindamycin Phosphate

ANDA 62801, held by Almaject. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 62801 (Clindamycin Phosphate), held by Almaject, was first approved by FDA on Jul 24, 1987, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1987
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jul 24, 1987	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 23 submissions, including labeling and manufacturing supplements


May 28, 2026	Supplement 36Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 35Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 34Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 33Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 31Labeling · Standard review	Approved	None posted
Jun 13, 2015	Supplement 30Labeling · Standard review	Approved	None posted
Jan 18, 2013	Supplement 27Labeling · Standard review	Approved	None posted
Oct 8, 2008	Supplement 23Labeling	Approved	None posted
Aug 12, 2005	Supplement 19Labeling	Approved	None posted
Apr 16, 2004	Supplement 17Labeling	Approved	None posted
Apr 9, 2001	Supplement 15Manufacturing	Approved	None posted
Jan 23, 2001	Supplement 14Manufacturing	Approved	None posted
Oct 26, 2000	Supplement 13Labeling	Approved	None posted
Feb 19, 1999	Supplement 11Manufacturing	Approved	None posted
Feb 19, 1999	Supplement 10Manufacturing	Approved	None posted
Aug 3, 1998	Supplement 12Manufacturing	Approved	None posted
May 10, 1995	Supplement 9Manufacturing	Approved	None posted
Mar 11, 1994	Supplement 7Labeling	Approved	None posted
Feb 24, 1994	Supplement 8Manufacturing	Approved	None posted
Oct 30, 1992	Supplement 6Manufacturing	Approved	None posted
Oct 22, 1991	Supplement 3Labeling	Approved	None posted
Feb 8, 1990	Supplement 4Manufacturing	Approved	None posted
Jul 24, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 62801
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