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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 011751

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PROLIXIN (FLUPHENAZINE HYDROCHLORIDE)
2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUPHENAZINE HYDROCHLORIDE
Proprietary Name: PROLIXIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N011751
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
PROLIXIN (FLUPHENAZINE HYDROCHLORIDE)
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUPHENAZINE HYDROCHLORIDE
Proprietary Name: PROLIXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N011751
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
PROLIXIN (FLUPHENAZINE HYDROCHLORIDE)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUPHENAZINE HYDROCHLORIDE
Proprietary Name: PROLIXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N011751
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
PROLIXIN (FLUPHENAZINE HYDROCHLORIDE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUPHENAZINE HYDROCHLORIDE
Proprietary Name: PROLIXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **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: N011751
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
PROLIXIN (FLUPHENAZINE HYDROCHLORIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUPHENAZINE HYDROCHLORIDE
Proprietary Name: PROLIXIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **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: N011751
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
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