Clindamycin Phosphate

ANDA 63282, held by Teva Parenteral. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 63282 (Clindamycin Phosphate), held by Teva Parenteral, was first approved by FDA on May 29, 1992, with 2 approved supplements and 0 published complete response letters.

First approved: May 29, 1992
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 29, 1992	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 3 submissions, including labeling and manufacturing supplements


Jan 20, 2000	Supplement 2Labeling	Approved	None posted
Jan 7, 1994	Supplement 1Manufacturing	Approved	None posted
May 29, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 63282
Drugs@FDA: Overview at FDA
Company: Teva Parenteral Medicines

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