← FDA Drug Approvals (Drugs@FDA)
ISOSORBIDE MONONITRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DEXCEL LTD · Approved 2018-08-29
Drug application
- FDA Application #
ANDA210822- 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
- Prescription
- Sponsor
- DEXCEL LTD
- Manufacturer
- Chartwell RX, LLC
- First approval
- 2018-08-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown