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DICLOFENAC SODIUM AND MISOPROSTOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: YUNG SHIN PHARM · Approved 2020-02-19

Drug application

FDA Application #

ANDA205143

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

YUNG SHIN PHARM

Manufacturer

Nivagen Pharmaceuticals, Inc.

First approval

2020-02-19

Source

Authoritative

Drugs@FDA application overview

Machine

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