Clindamycin Phosphate

ANDA 62889, held by Hikma. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 62889 (Clindamycin Phosphate), held by Hikma, was first approved by FDA on Apr 25, 1988, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 25, 1988
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 25, 1988	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Nov 14, 1995	Supplement 8Manufacturing	Approved	None posted
Aug 30, 1994	Supplement 7Manufacturing	Approved	None posted
Apr 26, 1993	Supplement 6Labeling	Approved	None posted
Jun 18, 1991	Supplement 5Labeling	Approved	None posted
Jun 26, 1990	Supplement 3Manufacturing	Approved	None posted
Feb 21, 1989	Supplement 2Manufacturing	Approved	None posted
Sep 29, 1988	Supplement 1Manufacturing	Approved	None posted
Apr 25, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 62889
Drugs@FDA: Overview at FDA
Company: Hikma

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