Phentermine Hydrochloride

ANDA 40555, held by Lannett. Phentermine Hydrochloride.

As of Nov 15, 2026, ANDA 40555 (Phentermine Hydrochloride), held by Lannett, was first approved by FDA on Apr 15, 2005, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 15, 2005
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 15, 2005	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


May 31, 2017	Supplement 16Labeling · Standard review	Approved	None posted
Dec 5, 2012	Supplement 10Labeling · Standard review	Approved	None posted
Apr 27, 2012	Supplement 9Labeling	Approved	None posted
Aug 22, 2011	Supplement 8Manufacturing	Approved	None posted
Apr 15, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 40555
Drugs@FDA: Overview at FDA
Company: Lannett Company

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