← FDA Drug Approvals (Drugs@FDA)
ISOSORBIDE DINITRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA INTL PHARMS · Approved 1987-11-02
Drug application
- FDA Application #
ANDA088088- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ISOSORBIDE DINITRATE
- Generic name
- ISOSORBIDE DINITRATE
- Active ingredients
- ISOSORBIDE DINITRATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HIKMA INTL PHARMS
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- First approval
- 1987-11-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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