Phentermine Hydrochloride

ANDA 84487, held by Upsher Smith Labs. Phentermine Hydrochloride.

As of Nov 15, 2026, ANDA 84487 (Phentermine Hydrochloride), held by Upsher Smith Labs, was first approved by FDA on Apr 9, 1982, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 9, 1982
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 9, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phentermine Hydrochloride30MG · capsule;oral	Phentermine Hydrochloride	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Sep 17, 1996	Supplement 20Manufacturing	Approved	None posted
Jan 14, 1991	Supplement 19Labeling	Approved	None posted
Sep 22, 1989	Supplement 18Labeling	Approved	None posted
Apr 5, 1989	Supplement 17Manufacturing	Approved	None posted
Jul 3, 1986	Supplement 9Manufacturing	Approved	None posted
May 30, 1986	Supplement 10Manufacturing	Approved	None posted
May 22, 1986	Supplement 8Manufacturing	Approved	None posted
May 22, 1986	Supplement 4Manufacturing	Approved	None posted
May 22, 1986	Supplement 3Manufacturing	Approved	None posted
Oct 8, 1985	Supplement 7Manufacturing	Approved	None posted
Jul 2, 1982	Supplement 1Manufacturing	Approved	None posted
Apr 9, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 84487
Drugs@FDA: Overview at FDA
Company: Upsher-Smith 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