APPLICATION
ANDA210549
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-23
LATEST ACTION
2022-10-31
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
AZELAIC ACIDPrescription
AZELAIC ACID 15% · GEL · TOPICAL
Approval history
2022-10-31Labeling · Supplement 5 · standardAP
2022-10-31Labeling · Supplement 4 · standardAP
2019-08-23UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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