← FDA Drug Approvals (Drugs@FDA)
BIDIL
NDA · New Drug Application · Sponsor: AZURITY · Approved 2005-06-23
Drug application
- FDA Application #
NDA020727
- Application type
- New Drug Application
- Brand name
- BIDIL
- Generic name
- HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE
- Active ingredients
- HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AZURITY
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- First approval
- 2005-06-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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