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DICLOFENAC SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: INGENUS PHARMS LLC · Approved 2022-09-23

Drug application

FDA Application #

ANDA216275

Application type

Abbreviated New Drug Application (Generic)

Brand name

DICLOFENAC SODIUM

Generic name

DICLOFENAC SODIUM

Active ingredients

DICLOFENAC SODIUM

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

INGENUS PHARMS LLC

Manufacturer

Ingenus Pharmaceuticals, LLC

First approval

2022-09-23

Source

Authoritative

Drugs@FDA application overview

Machine

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