Clobetasol Propionate

ANDA 90898, held by Padagis US. Clobetasol Propionate.

As of Nov 15, 2026, ANDA 90898 (Clobetasol Propionate), held by Padagis US, was first approved by FDA on Jun 16, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 16, 2011
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 16, 2011	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clobetasol Propionate0.05% · spray;topical	Clobetasol Propionate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 6, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Sep 6, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Nov 17, 2017	Supplement 3Manufacturing	Approved	None posted
Nov 17, 2017	Supplement 1Labeling · Standard review	Approved	None posted
Jun 16, 2011	Original application	Approved	Review

Identifiers

Application: ANDA 90898
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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