Nefazodone Hydrochloride

ANDA 76072, held by Ani Pharms. Nefazodone Hydrochloride.

As of Nov 15, 2026, ANDA 76072 (Nefazodone Hydrochloride), held by Ani Pharms, was first approved by FDA on Sep 16, 2003, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 16, 2003
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 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	Discontinued
Nefazodone Hydrochloride100MG · tablet;oral	Nefazodone Hydrochloride	Discontinued
Nefazodone Hydrochloride150MG · tablet;oral	Nefazodone Hydrochloride	Discontinued
Nefazodone Hydrochloride200MG · tablet;oral	Nefazodone Hydrochloride	Discontinued
Nefazodone Hydrochloride250MG · tablet;oral	Nefazodone Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Sep 16, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76072
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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