Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020727

BIDIL (HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE)
37.5MG;20MG
Marketing Status: Prescription
Active Ingredient: HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Proprietary Name: BIDIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 37.5MG;20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020727
Product Number: 001
Approval Date: Jun 23, 2005
Applicant Holder Full Name: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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