# DICLOFENAC SODIUM AND MISOPROSTOL
> **ANDA205143** · Abbreviated New Drug Application (Generic) · Sponsor: YUNG SHIN PHARM · Approved 2020-02-19
## Drug
- **FDA Application Number:** ANDA205143
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DICLOFENAC SODIUM AND MISOPROSTOL
- **Generic name:** DICLOFENAC SODIUM AND MISOPROSTOL
- **Active ingredients:** DICLOFENAC SODIUM; MISOPROSTOL
- **Dosage form:** TABLET, DELAYED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** YUNG SHIN PHARM
- **Manufacturer:** Nivagen Pharmaceuticals, Inc.
- **First approval:** 2020-02-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205143)
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