Clindamycin Phosphate

ANDA 62800, held by Almaject. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 62800 (Clindamycin Phosphate), held by Almaject, was first approved by FDA on Jul 24, 1987, with 18 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1987
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 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 19 submissions, including labeling and manufacturing supplements


May 28, 2026	Supplement 41Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 40Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 39Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 38Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 36Labeling · Standard review	Approved	None posted
May 28, 2026	Supplement 35Labeling · Standard review	Approved	None posted
Jan 18, 2013	Supplement 31Labeling · Standard review	Approved	None posted
Oct 10, 2008	Supplement 25Labeling	Approved	None posted
Aug 12, 2005	Supplement 20Labeling	Approved	None posted
Jul 12, 2004	Supplement 15Labeling	Approved	None posted
Jan 23, 2001	Supplement 13Manufacturing	Approved	None posted
Oct 26, 2000	Supplement 12Labeling	Approved	None posted
Aug 3, 1998	Supplement 11Manufacturing	Approved	None posted
Jan 17, 1995	Supplement 10Labeling	Approved	None posted
Jun 20, 1994	Supplement 9Labeling	Approved	None posted
Feb 28, 1994	Supplement 7Labeling	Approved	None posted
Feb 24, 1994	Supplement 8Manufacturing	Approved	None posted
Oct 22, 1991	Supplement 4Labeling	Approved	None posted
Jul 24, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 62800
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