Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208258
Company: SUN PHARMA CANADA

Products on ANDA 208258

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAZAROTENE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208258

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/2017	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208258Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208258Orig1s000ltr.pdf

Labels for ANDA 208258

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208258Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 208258

TAZAROTENE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVAGE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	021184	ALMIRALL
TAZAROTENE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208662	COSETTE
TAZAROTENE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208258	SUN PHARMA CANADA
TAZORAC	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	021184	ALMIRALL