Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204637
Company: GLENMARK PHARMS

Products on ANDA 204637

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204637

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			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204637Orig1s000TAltr.pdf

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.
07/01/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204637

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	208724	ENCUBE
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
FINACEA	AZELAIC ACID	15%	GEL;TOPICAL	Prescription	Yes	AB	021470	LEO PHARMA AS