DICLOFENAC SODIUM MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
Summary
FDA approved DICLOFENAC SODIUM MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) by YUNG SHIN PHARM. ANDA (Generic) approval (Manufacturing (CMC)) on 2024-12-23. TABLET, DELAYED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA205143-8
Action Date
2024-12-23
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
DICLOFENAC SODIUM MISOPROSTOL (generic: DICLOFENAC SODIUM AND MISOPROSTOL), TABLET, DELAYED RELEASE, ORAL. Application: ANDA205143
Company
Context & Analysis
YUNG SHIN PHARM has 3 FDA actions in our database.
Frequently Asked Questions
How often does YUNG SHIN PHARM have FDA actions?
YUNG SHIN PHARM has 3 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA205143-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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