Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203845

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HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
25MG
Marketing Status: Prescription

Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Proprietary Name: HYDRALAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203845
Product Number: 001
Approval Date: Sep 18, 2014
Applicant Holder Full Name: CADILA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
50MG
Marketing Status: Prescription

Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Proprietary Name: HYDRALAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203845
Product Number: 002
Approval Date: Sep 18, 2014
Applicant Holder Full Name: CADILA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
100MG
Marketing Status: Prescription

Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Proprietary Name: HYDRALAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A203845
Product Number: 003
Approval Date: Sep 18, 2014
Applicant Holder Full Name: CADILA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information