Nefazodone Hydrochloride

Treats depression. ANDA 76037, held by Teva. Nefazodone Hydrochloride.

As of Nov 15, 2026, ANDA 76037 (Nefazodone Hydrochloride), held by Teva, was first approved by FDA on Sep 16, 2003, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 16, 2003
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS ). In many cases, this would lead to the conclusion that other drugs should be tried first.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Sep 16, 2003	Original application	Approved	None posted

Products

5 strengths and forms


Nefazodone Hydrochloride50MG · tablet;oral	Nefazodone Hydrochloride	Rx
Nefazodone Hydrochloride100MG · tablet;oral	Nefazodone Hydrochloride	Rx
Nefazodone Hydrochloride150MG · tablet;oral	Nefazodone Hydrochloride	Rx
Nefazodone Hydrochloride200MG · tablet;oral	Nefazodone Hydrochloride	Rx
Nefazodone Hydrochloride250MG · tablet;oral	Nefazodone Hydrochloride	Rx

All 10 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Jun 16, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 11Labeling · Standard review	Approved	Label
Jan 20, 2011	Supplement 10Manufacturing	Approved	None posted
Jan 13, 2011	Supplement 9Manufacturing	Approved	None posted
Oct 29, 2007	Supplement 4Labeling	Approved	None posted
Oct 29, 2007	Supplement 6Labeling	Approved	None posted
Oct 25, 2005	Supplement 2Labeling	Approved	None posted
Feb 18, 2005	Supplement 1Labeling	Approved	None posted
Sep 16, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76037
Drugs@FDA: Overview at FDA
Company: Teva 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