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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021184
Company: ALLERGAN

Products on NDA 021184

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVAGE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	AB	Yes	Yes
TAZORAC	TAZAROTENE	0.05%	CREAM;TOPICAL	Prescription	None	Yes	Yes
TAZORAC	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021184

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21184lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21184ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-184_Tazorac.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)	Label for Avage and Tazorac	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021184s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021184Orig1s009,020600Orig1s009ltr.pdf
09/16/2016	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)	Avage label updated	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021184s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021184Orig1s008ltr.pdf
12/13/2013	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)	Tazorac label updated	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021184s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021184Orig1s007ltr.pdf
09/30/2002	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21184s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21184se1-002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-184s002_Avage.cfm
10/11/2001	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21184s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21184s1ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-184S001_Tazorac.cfm

Labels for NDA 021184

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)	Label for Avage and Tazorac	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021184s009lbl.pdf
09/16/2016	SUPPL-8	Labeling-Package Insert	Label (PDF)	Avage label updated	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021184s008lbl.pdf
12/13/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)	Tazorac label updated	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021184s007lbl.pdf
09/30/2002	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21184s2lbl.pdf
10/11/2001	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21184s1lbl.pdf
09/29/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21184lbl.pdf

Therapeutic Equivalents for NDA 021184

AVAGE

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	ALLERGAN
TAZAROTENE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208662	COSETTE
TAZAROTENE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208258	TARO PHARMS
TAZORAC	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	021184	ALLERGAN

TAZORAC

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	ALLERGAN
TAZAROTENE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208662	COSETTE
TAZAROTENE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208258	TARO PHARMS
TAZORAC	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	021184	ALLERGAN

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