Cleocin Phosphate In Dextrose 5% In Plastic Container

NDA 50639, held by Pfizer. Clindamycin Phosphate.

As of Nov 15, 2026, NDA 50639 (Cleocin Phosphate In Dextrose 5% In Plastic Container), held by Pfizer, was first approved by FDA on Aug 30, 1989, with 35 approved supplements and 0 published complete response letters.

First approved: Aug 30, 1989
Review: Standard
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Aug 30, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Cleocin Phosphate In Dextrose 5% In Plastic ContainerEQ 6MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Clindamycin Phosphate	DiscontinuedReference drug
Cleocin Phosphate In Dextrose 5% In Plastic ContainerEQ 12MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Clindamycin Phosphate	DiscontinuedReference drug
Cleocin Phosphate In Dextrose 5% In Plastic ContainerEQ 18MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Clindamycin Phosphate	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements


Mar 26, 2026	Supplement 45Labeling · Standard review	Approved	Label Letter
Feb 12, 2026	Supplement 44Labeling · Standard review	Approved	Label Letter
May 20, 2022	Supplement 42Labeling · Standard review	Approved	Letter Label
Dec 4, 2021	Supplement 43Labeling · Standard review	Approved	Label Letter
Mar 4, 2020	Supplement 41Labeling · Standard review	Approved	Letter Label
Jun 19, 2019	Supplement 40Labeling · Standard review	Approved	Label Letter
Apr 16, 2018	Supplement 38Labeling · Standard review	Approved	Label Letter
May 2, 2017	Supplement 35Labeling · Standard review	Approved	Letter Label
May 2, 2017	Supplement 37Labeling · Standard review	Approved	Letter Label
Aug 5, 2016	Supplement 33Labeling · Standard review	Approved	Letter Label
Aug 5, 2016	Supplement 34Labeling · Standard review	Approved	Letter Label
May 20, 2016	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 24, 2016	Supplement 31Labeling · Standard review	Approved	Label Letter
Sep 18, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Jun 25, 2014	Supplement 29Labeling · Standard review	Approved	Label Letter
Jun 25, 2014	Supplement 28Labeling · Standard review	Approved	Label Letter
Jun 25, 2014	Supplement 27Labeling · Standard review	Approved	Label Letter
Oct 9, 2013	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 26, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 7, 2011	Supplement 22Labeling	Approved	Letter
Apr 14, 2008	Supplement 16Labeling · Standard review	Approved	Label Letter
Feb 21, 2008	Supplement 15Labeling · Standard review	Approved	Label Letter
Sep 29, 2004	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 28, 2004	Supplement 14Labeling · Standard review	Approved	Letter
Mar 9, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 12, 1997	Supplement 12Labeling · Standard review	Approved	None posted
Jul 17, 1997	Supplement 11Labeling · Standard review	Approved	None posted
Mar 17, 1997	Supplement 5Labeling	Approved	None posted
Dec 20, 1995	Supplement 7Labeling · Standard review	Approved	None posted
Feb 21, 1995	Supplement 9Labeling · Standard review	Approved	None posted
Apr 5, 1993	Supplement 8Manufacturing · Standard review	Approved	None posted
May 21, 1992	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 11, 1991	Supplement 2Labeling	Approved	None posted
Apr 18, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 10, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 30, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50639
Drugs@FDA: Overview at FDA
Company: Pfizer

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