Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208662
Company: COSETTE PHARMS NC

Products on ANDA 208662

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208662

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/10/2025	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208662

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 PHARMS NC
TAZAROTENE	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208258	SUN PHARMA CANADA
TAZORAC	TAZAROTENE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	021184	ALMIRALL

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 PHARMS NC
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