Alphatrex

NDA 19143, held by Savage Labs. Betamethasone Dipropionate.

As of Nov 14, 2026, NDA 19143 (Alphatrex), held by Savage Labs, was first approved by FDA on Sep 4, 1984, with 12 approved supplements and 0 published complete response letters.

First approved: Sep 4, 1984
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Sep 4, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AlphatrexEQ 0.05% BASE · ointment;topical	Betamethasone Dipropionate	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Nov 1, 1996	Supplement 12Labeling	Approved	None posted
Jun 13, 1996	Supplement 11Manufacturing	Approved	None posted
Mar 7, 1996	Supplement 13Manufacturing	Approved	None posted
Jul 16, 1992	Supplement 10Manufacturing	Approved	None posted
Nov 1, 1988	Supplement 9Manufacturing	Approved	None posted
Nov 1, 1988	Supplement 8Manufacturing	Approved	None posted
Nov 1, 1988	Supplement 7Manufacturing	Approved	None posted
Oct 20, 1987	Supplement 4Manufacturing	Approved	None posted
Jul 6, 1987	Supplement 5Manufacturing	Approved	None posted
May 29, 1987	Supplement 6Manufacturing	Approved	None posted
Jun 27, 1986	Supplement 2Manufacturing	Approved	None posted
Mar 28, 1986	Supplement 1Manufacturing	Approved	None posted
Sep 4, 1984	Original application	Approved	None posted

Identifiers

Application: NDA 19143
Drugs@FDA: Overview at FDA
Company: Savage Laboratories

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