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DICLOFENAC SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ENCUBE · Approved 2020-01-27

Drug application

FDA Application #
ANDA210986
Application type
Abbreviated New Drug Application (Generic)
Brand name
DICLOFENAC SODIUM
Generic name
DICLOFENAC SODIUM TOPICAL GEL, 1%
Active ingredients
DICLOFENAC SODIUM
Dosage form
GEL
Route
TOPICAL
Marketing status
Over-the-counter
Sponsor
ENCUBE
Manufacturer
BluePoint Laboratories
First approval
2020-01-27

Source

Authoritative
Drugs@FDA application overview
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