← FDA Drug Approvals (Drugs@FDA)
DICLOFENAC SODIUM AND MISOPROSTOL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2023-06-12
Drug application
- FDA Application #
ANDA206771
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DICLOFENAC SODIUM AND MISOPROSTOL
- Generic name
- Diclofenac Sodium
- Active ingredients
- DICLOFENAC SODIUM; MISOPROSTOL
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- ZYDUS PHARMS
- First approval
- 2023-06-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown