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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208724
Company: TOLMAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZELAIC ACID AZELAIC ACID 15% GEL;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/19/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/01/2022 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

AZELAIC ACID

GEL;TOPICAL; 15%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZELAIC ACID AZELAIC ACID 15% GEL;TOPICAL Prescription No AB 208011 ACTAVIS LABS UT INC
AZELAIC ACID AZELAIC ACID 15% GEL;TOPICAL Prescription No AB 204637 GLENMARK PHARMS
AZELAIC ACID AZELAIC ACID 15% GEL;TOPICAL Prescription No AB 210549 TARO
AZELAIC ACID AZELAIC ACID 15% GEL;TOPICAL Prescription No AB 208724 TOLMAR
FINACEA AZELAIC ACID 15% GEL;TOPICAL Prescription Yes AB 021470 LEO PHARMA AS
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