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DICLOFENAC SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ENCUBE · Approved 2025-04-09

Drug application

FDA Application #
ANDA217646
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
ENCUBE
Manufacturer
Encube Ethicals, Inc.
First approval
2025-04-09

Source

Authoritative
Drugs@FDA application overview
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