Phentermine Hydrochloride

ANDA 40448, held by Elite Labs Inc. Phentermine Hydrochloride.

As of Nov 15, 2026, ANDA 40448 (Phentermine Hydrochloride), held by Elite Labs Inc, was first approved by FDA on Jan 22, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 22, 2003
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 22, 2003	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


May 31, 2017	Supplement 4Labeling · Standard review	Approved	None posted
Jan 22, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40448
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