Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 008303

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APRESOLINE (HYDRALAZINE HYDROCHLORIDE)
20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Proprietary Name: APRESOLINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N008303
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

APRESOLINE (HYDRALAZINE HYDROCHLORIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Proprietary Name: APRESOLINE
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Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N008303
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

APRESOLINE (HYDRALAZINE HYDROCHLORIDE)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Proprietary Name: APRESOLINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N008303
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

APRESOLINE (HYDRALAZINE HYDROCHLORIDE)
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Proprietary Name: APRESOLINE
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: N008303
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

APRESOLINE (HYDRALAZINE HYDROCHLORIDE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Proprietary Name: APRESOLINE
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: N008303
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information