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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020152

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SERZONE (NEFAZODONE HYDROCHLORIDE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: SERZONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020152
Product Number: 001
Approval Date: Dec 22, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status:  Discontinued
Patent and Exclusivity Information
SERZONE (NEFAZODONE HYDROCHLORIDE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: SERZONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020152
Product Number: 002
Approval Date: Dec 22, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status:  Discontinued
Patent and Exclusivity Information
SERZONE (NEFAZODONE HYDROCHLORIDE)
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: SERZONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020152
Product Number: 003
Approval Date: Dec 22, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status:  Discontinued
Patent and Exclusivity Information
SERZONE (NEFAZODONE HYDROCHLORIDE)
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: SERZONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020152
Product Number: 004
Approval Date: Dec 22, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status:  Discontinued
Patent and Exclusivity Information
SERZONE (NEFAZODONE HYDROCHLORIDE)
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: SERZONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020152
Product Number: 005
Approval Date: Dec 22, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status:  Discontinued
Patent and Exclusivity Information
SERZONE (NEFAZODONE HYDROCHLORIDE)
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NEFAZODONE HYDROCHLORIDE
Proprietary Name: SERZONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020152
Product Number: 006
Approval Date: Dec 22, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status:  Discontinued
Patent and Exclusivity Information
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