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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 089097

HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
10MG
Marketing Status: Prescription
Active Ingredient: HYDRALAZINE HYDROCHLORIDE
Proprietary Name: HYDRALAZINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A089097
Product Number: 001
Approval Date: Dec 18, 1985
Applicant Holder Full Name: PLIVA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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