Phentermine Hydrochloride

ANDA 88596, held by Chartwell Rx. Phentermine Hydrochloride.

As of Nov 15, 2026, ANDA 88596 (Phentermine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Apr 4, 1984, with 14 approved supplements and 0 published complete response letters.

First approved: Apr 4, 1984
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Apr 4, 1984	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phentermine Hydrochloride37.5MG · tablet;oral	Phentermine Hydrochloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Jul 26, 2000	Supplement 18Manufacturing	Approved	None posted
Nov 3, 1998	Supplement 17Labeling	Approved	None posted
Aug 19, 1998	Supplement 16Labeling	Approved	None posted
Apr 8, 1998	Supplement 15Labeling	Approved	None posted
Dec 19, 1997	Supplement 14Labeling	Approved	None posted
Oct 16, 1992	Supplement 13Manufacturing	Approved	None posted
Jan 31, 1991	Supplement 11Labeling	Approved	None posted
May 24, 1990	Supplement 10Labeling	Approved	None posted
Dec 15, 1989	Supplement 9Labeling	Approved	None posted
Jun 15, 1989	Supplement 5Labeling	Approved	None posted
Jun 15, 1989	Supplement 8Labeling	Approved	None posted
Jun 27, 1988	Supplement 6Manufacturing	Approved	None posted
Jun 27, 1988	Supplement 7Manufacturing	Approved	None posted
May 22, 1986	Supplement 2Manufacturing	Approved	None posted
Apr 4, 1984	Original application	Approved	Review

Identifiers

Application: ANDA 88596
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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