Fastin

NDA 17352, held by Glaxosmithkline. Phentermine Hydrochloride.

As of Nov 14, 2026, NDA 17352 (Fastin), held by Glaxosmithkline, was first approved by FDA on Aug 14, 1973, with 15 approved supplements and 0 published complete response letters.

First approved: Aug 14, 1973
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Aug 14, 1973	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fastin30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Phentermine Hydrochloride	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Jul 16, 1998	Supplement 19Labeling · Standard review	Approved	None posted
Jan 16, 1998	Supplement 18Labeling · Standard review	Approved	None posted
Oct 10, 1997	Supplement 17Labeling · Standard review	Approved	None posted
Apr 24, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 31, 1984	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 31, 1981	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 31, 1981	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 17, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 26, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 29, 1980	Supplement 6Labeling · Standard review	Approved	None posted
Oct 11, 1978	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 2, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 3, 1975	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 22, 1975	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 10, 1975	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 14, 1973	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17352
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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