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AZELAIC ACID

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARMA CANADA · Approved 2019-08-23

Drug application

FDA Application #
ANDA210549
Application type
Abbreviated New Drug Application (Generic)
Brand name
AZELAIC ACID
Generic name
AZELAIC ACID
Active ingredients
AZELAIC ACID
Dosage form
GEL
Route
TOPICAL
Marketing status
Prescription
Sponsor
SUN PHARMA CANADA
Manufacturer
Sun Pharmaceutical Industries, Inc.
First approval
2019-08-23

Source

Authoritative
Drugs@FDA application overview
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