← FDA Drug Approvals (Drugs@FDA)
DICLOFENAC SODIUM AND MISOPROSTOL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2012-07-09
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
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