← FDA Drug Approvals (Drugs@FDA)
ISOSORBIDE DINITRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RUBICON · Approved 2022-07-08
Drug application
- FDA Application #
ANDA215723- 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
- RUBICON
- Manufacturer
- Advagen Pharma Ltd
- First approval
- 2022-07-08
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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