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DICLOFENAC SODIUM AND MISOPROSTOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MICRO LABS · Approved 2021-07-15

Drug application

FDA Application #

ANDA204355

Application type

Abbreviated New Drug Application (Generic)

Brand name

DICLOFENAC SODIUM AND MISOPROSTOL

Generic name

DICLOFENAC SODIUM/MISOPROSTOL

Active ingredients

DICLOFENAC SODIUM; MISOPROSTOL

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

MICRO LABS

Manufacturer

Micro Labs Limited

First approval

2021-07-15

Source

Authoritative

Drugs@FDA application overview

Machine

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