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DICLOFENAC SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2022-08-18

Drug application

FDA Application #

ANDA208198

Application type

Abbreviated New Drug Application (Generic)

Brand name

DICLOFENAC SODIUM

Generic name

DICLOFENAC

Active ingredients

DICLOFENAC SODIUM

Dosage form

SOLUTION

Route

TOPICAL

Marketing status

Prescription

Sponsor

AMNEAL

Manufacturer

Amneal Pharmaceuticals LLC

First approval

2022-08-18

Source

Authoritative

Drugs@FDA application overview

Machine

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