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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217075
Company: PADAGIS ISRAEL

Products on ANDA 217075

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217075

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217075

TAZAROTENE

CREAM;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%	CREAM;TOPICAL	Prescription	No	AB	208662	COSETTE
TAZAROTENE	TAZAROTENE	0.05%	CREAM;TOPICAL	Prescription	No	AB	217075	PADAGIS ISRAEL
TAZAROTENE	TAZAROTENE	0.05%	CREAM;TOPICAL	Prescription	No	AB	214560	SOLARIS PHARMA CORP
TAZORAC	TAZAROTENE	0.05%	CREAM;TOPICAL	Prescription	Yes	AB	021184	ALMIRALL

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