Clindamycin Phosphate

ANDA 206945, held by Pai Holdings Pharm. Clindamycin Phosphate.

As of Nov 15, 2026, ANDA 206945 (Clindamycin Phosphate), held by Pai Holdings Pharm, was first approved by FDA on Dec 30, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 30, 2016
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 30, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clindamycin PhosphateEQ 1% BASE · solution;topical	Clindamycin Phosphate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Apr 6, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Apr 6, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Apr 6, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Dec 30, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206945
Drugs@FDA: Overview at FDA
Company: PAI Holdings Pharm

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