# ARTHROTEC
> **NDA020607** · New Drug Application · Sponsor: PFIZER · Approved 1997-12-24
## Drug
- **FDA Application Number:** NDA020607
- **Application type:** New Drug Application
- **Brand name:** ARTHROTEC
- **Generic name:** DICLOFENAC SODIUM AND MISOPROSTOL
- **Active ingredients:** DICLOFENAC SODIUM; MISOPROSTOL
- **Dosage form:** TABLET, DELAYED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PFIZER
- **Manufacturer:** Mylan Pharmaceuticals Inc.
- **First approval:** 1997-12-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020607)
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