Clindamycin Phosphate

Treats serious infections caused by susceptible anaerobic bacteria. ANDA 90109, held by Sagent Pharms Inc. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 90109 (Clindamycin Phosphate), held by Sagent Pharms Inc, was first approved by FDA on Sep 30, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 30, 2011
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection, USP is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Sep 30, 2011	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 11 submissions, including labeling and manufacturing supplements


Jul 13, 2026	Supplement 21Labeling · Standard review	Approved	None posted
Jul 13, 2026	Supplement 22Labeling · Standard review	Approved	None posted
Feb 9, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Feb 9, 2021	Supplement 15Labeling · Standard review	Approved	None posted
Feb 9, 2021	Supplement 16Labeling · Standard review	Approved	None posted
Apr 16, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Apr 16, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Apr 16, 2018	Supplement 11Labeling · Standard review	Approved	None posted
Apr 16, 2018	Supplement 12Labeling · Standard review	Approved	None posted
Dec 27, 2011	Supplement 1Labeling	Approved	None posted
Sep 30, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90109
Drugs@FDA: Overview at FDA
Company: Sagent Pharmaceuticals

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