# ISOSORBIDE MONONITRATE
> **ANDA210822** · Abbreviated New Drug Application (Generic) · Sponsor: DEXCEL LTD · Approved 2018-08-29
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210822)
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