Serzone

NDA 20152, held by Bristol Myers Squibb. Nefazodone Hydrochloride.

As of Nov 14, 2026, NDA 20152 (Serzone), held by Bristol Myers Squibb, was first approved by FDA on Dec 22, 1994, with 35 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1994
Review: Standard
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below


Mar 13, 2009	Supplement 32Efficacy (new indication or use) · Priority review	Approved	None posted
Dec 22, 1994	Original applicationNew molecular entity · Standard review	Approved	Pediatric Medical Review Pediatric Written Request Pediatric Clinical Pharmacology Review

Products

6 strengths and forms


Serzone50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nefazodone Hydrochloride	DiscontinuedReference drug
Serzone100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nefazodone Hydrochloride	DiscontinuedReference drug
Serzone150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nefazodone Hydrochloride	DiscontinuedReference drug
Serzone200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nefazodone Hydrochloride	DiscontinuedReference drug
Serzone250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nefazodone Hydrochloride	DiscontinuedReference drug
Serzone300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nefazodone Hydrochloride	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 32Efficacy (new indication or use) · Priority review	Approved	None posted
Mar 13, 2009	Supplement 14Labeling · Standard review	Approved	None posted
Jan 12, 2005	Supplement 35Labeling · Standard review	Approved	Letter Label
May 27, 2004	Supplement 34Labeling · Standard review	Approved	Letter
May 5, 2003	Supplement 31Labeling · Standard review	Approved	Review Letter
Jun 20, 2002	Supplement 33Labeling · Standard review	Approved	Letter
Apr 23, 2002	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 11, 2002	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 8, 2002	Supplement 29Labeling · Standard review	Approved	Letter
Dec 4, 2001	Supplement 28Labeling · Standard review	Approved	Review Letter
Mar 21, 2001	Supplement 26Labeling · Standard review	Approved	Review Letter
Jan 23, 2001	Supplement 25Labeling · Standard review	Approved	None posted
Nov 9, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 26, 2000	Supplement 6Labeling · Standard review	Approved	Review
Jun 1, 2000	Supplement 23Labeling · Standard review	Approved	None posted
Jun 1, 2000	Supplement 19Labeling · Standard review	Approved	None posted
Jun 1, 2000	Supplement 17Labeling · Standard review	Approved	None posted
Jun 1, 2000	Supplement 16Labeling · Standard review	Approved	None posted
Jun 1, 2000	Supplement 15Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 22Manufacturing · Standard review	Approved	None posted
Nov 30, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 23, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 9, 1999	Supplement 20Labeling · Standard review	Approved	None posted
Jan 27, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 31, 1998	Supplement 11Labeling · Standard review	Approved	Letter
Aug 6, 1997	Supplement 12Labeling · Standard review	Approved	None posted
May 5, 1997	Supplement 10Labeling · Standard review	Approved	Review
May 5, 1997	Supplement 9Labeling · Standard review	Approved	Review
Feb 6, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 13, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 2, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 25, 1996	Supplement 3Labeling · Standard review	Approved	None posted
Mar 28, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 28, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 20, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 22, 1994	Original applicationNew molecular entity · Standard review	Approved	Pediatric Medical Review Pediatric Written Request Pediatric Clinical Pharmacology Review

Identifiers

Application: NDA 20152
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

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