# DICLOFENAC SODIUM AND MISOPROSTOL
> **ANDA201089** · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2012-07-09
## Drug
- **FDA Application Number:** ANDA201089
- **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:** ACTAVIS LABS FL INC
- **Manufacturer:** BluePoint Laboratories
- **First approval:** 2012-07-09
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201089)
---
*MORVS · CC0 1.0*