← FDA Drug Approvals (Drugs@FDA)
ISOSORBIDE MONONITRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SKYEPHARMA AG · Approved 1999-10-07
Drug application
- FDA Application #
ANDA075166
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ISOSORBIDE MONONITRATE
- Generic name
- Isosorbide Mononitrate
- Active ingredients
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- SKYEPHARMA AG
- First approval
- 1999-10-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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