Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213079
Company: PADAGIS ISRAEL

Products on ANDA 213079

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAZAROTENE	TAZAROTENE	0.05%	GEL;TOPICAL	Prescription	AB	No	No
TAZAROTENE	TAZAROTENE	0.1%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213079

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213079

TAZAROTENE

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
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	ALLERGAN

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
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	ALLERGAN