Phentermine Hydrochloride

ANDA 40527, held by Sun Pharm Industries. Phentermine Hydrochloride.

As of Nov 15, 2026, ANDA 40527 (Phentermine Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Oct 23, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 23, 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
Oct 23, 2003	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


May 31, 2017	Supplement 10Labeling · Standard review	Approved	None posted
Oct 23, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40527
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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