# DICLOFENAC SODIUM AND MISOPROSTOL
> **ANDA203995** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2016-11-25
## Drug
- **FDA Application Number:** ANDA203995
- **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:** AMNEAL PHARMS
- **Manufacturer:** Amneal Pharmaceuticals LLC
- **First approval:** 2016-11-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203995)
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