Evoclin

NDA 50801, held by Quagen. Clindamycin Phosphate.

As of Nov 13, 2026, NDA 50801 (Evoclin), held by Quagen, was first approved by FDA on Oct 22, 2004, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2004
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 22, 2004	Original applicationNew dosage form · Standard review	Approved	Review Other Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Evoclin1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · aerosol, foam;topical	Clindamycin Phosphate	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Apr 17, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label
Jan 20, 2015	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 20, 2012	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 21, 2010	Supplement 11Labeling	Approved	Letter Label
Jul 11, 2006	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 22, 2004	Original applicationNew dosage form · Standard review	Approved	Review Other Letter Label

Identifiers

Application: NDA 50801
Drugs@FDA: Overview at FDA
Company: Quagen 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