Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020152
Company: BRISTOL MYERS SQUIBB

• Other Important Information from FDA

Products on NDA 20152

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SERZONE	NEFAZODONE HYDROCHLORIDE	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
SERZONE	NEFAZODONE HYDROCHLORIDE	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
SERZONE	NEFAZODONE HYDROCHLORIDE	150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
SERZONE	NEFAZODONE HYDROCHLORIDE	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
SERZONE	NEFAZODONE HYDROCHLORIDE	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
SERZONE	NEFAZODONE HYDROCHLORIDE	300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 020152

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2005	SUPPL-35	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20152s035lbl.pdf