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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
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