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DICLOFENAC SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARMA CANADA · Approved 2016-04-28

Drug application

FDA Application #
ANDA206298
Application type
Abbreviated New Drug Application (Generic)
Brand name
DICLOFENAC SODIUM
Generic name
DICLOFENAC SODIUM
Active ingredients
DICLOFENAC SODIUM
Dosage form
GEL
Route
TOPICAL
Marketing status
Prescription
Sponsor
SUN PHARMA CANADA
Manufacturer
Sun Pharmaceutical Industries, Inc.
First approval
2016-04-28

Source

Authoritative
Drugs@FDA application overview
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