Nefazodone Hydrochloride

ANDA 76196, held by Roxane. Nefazodone Hydrochloride.

As of Nov 15, 2026, ANDA 76196 (Nefazodone Hydrochloride), held by Roxane, was not approved, with 0 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 0
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jan 14, 2003	Original application	Tentative approval	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

Identifiers

Application: ANDA 76196
Drugs@FDA: Overview at FDA
Company: Roxane Laboratories

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