Phentermine Hydrochloride

ANDA 40227, held by Elite Labs Inc. Phentermine Hydrochloride.

As of Nov 15, 2026, ANDA 40227 (Phentermine Hydrochloride), held by Elite Labs Inc, was first approved by FDA on Jun 18, 1997, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 18, 1997
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
Jun 18, 1997	Original application	Approved	Review

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


May 31, 2017	Supplement 10Labeling · Standard review	Approved	None posted
Nov 14, 2002	Supplement 4Manufacturing	Approved	None posted
Sep 2, 1999	Supplement 3Manufacturing	Approved	None posted
May 7, 1999	Supplement 2Labeling	Approved	None posted
Aug 10, 1998	Supplement 1Labeling	Approved	None posted
Jun 18, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 40227
Drugs@FDA: Overview at FDA
Company: Elite 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