SERZONE — FDA application NDA020152

Application NDA020152 · type NDA · FDA status: approved · original approval 1994-12-22

Listed sponsor: BRISTOL MYERS SQUIBB · BMY company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	SERZONE	NEFAZODONE HYDROCHLORIDE	TABLET	ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
002	SERZONE	NEFAZODONE HYDROCHLORIDE	TABLET	ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
003	SERZONE	NEFAZODONE HYDROCHLORIDE	TABLET	ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
004	SERZONE	NEFAZODONE HYDROCHLORIDE	TABLET	ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
005	SERZONE	NEFAZODONE HYDROCHLORIDE	TABLET	ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
006	SERZONE	NEFAZODONE HYDROCHLORIDE	TABLET	ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

No Orange Book patent or exclusivity listings joined to this application.

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.