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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020600
Company: ALMIRALL

Products on NDA 020600

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAZORAC	TAZAROTENE	0.05%	GEL;TOPICAL	Prescription	AB	Yes	Yes
TAZORAC	TAZAROTENE	0.1%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020600

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020600_tazorac_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020600s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020600Orig1s010ltr.pdf
07/21/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020600s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021184Orig1s009,020600Orig1s009ltr.pdf
02/25/2011	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020600s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020600s008ltr.pdf
12/02/2003	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20600slr003,005ltr.pdf
12/02/2003	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20600slr003,005ltr.pdf
06/17/1999	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
06/17/1999	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020600

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020600s010lbl.pdf
07/21/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020600s009lbl.pdf
02/25/2011	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020600s008lbl.pdf
12/02/2003	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf
12/02/2003	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf

Therapeutic Equivalents for NDA 020600

TAZORAC

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TAZAROTENE	TAZAROTENE	0.05%	GEL;TOPICAL	Prescription	No	AB	215433	COSETTE PHARMS NC
TAZAROTENE	TAZAROTENE	0.05%	GEL;TOPICAL	Prescription	No	AB	213079	PADAGIS ISRAEL
TAZAROTENE	TAZAROTENE	0.05%	GEL;TOPICAL	Prescription	No	AB	213644	SOLARIS PHARMA CORP
TAZORAC	TAZAROTENE	0.05%	GEL;TOPICAL	Prescription	Yes	AB	020600	ALMIRALL

GEL;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TAZAROTENE	TAZAROTENE	0.1%	GEL;TOPICAL	Prescription	No	AB	214136	COSETTE PHARMS NC
TAZAROTENE	TAZAROTENE	0.1%	GEL;TOPICAL	Prescription	No	AB	213079	PADAGIS ISRAEL
TAZAROTENE	TAZAROTENE	0.1%	GEL;TOPICAL	Prescription	No	AB	213644	SOLARIS PHARMA CORP
TAZORAC	TAZAROTENE	0.1%	GEL;TOPICAL	Prescription	Yes	AB	020600	ALMIRALL

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