Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217190
Company: SUN PHARMA CANADA

Products on ANDA 217190

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALOBETASOL PROPIONATE AND TAZAROTENE	HALOBETASOL PROPIONATE; TAZAROTENE	0.01%;0.045%	LOTION;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217190

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217190

HALOBETASOL PROPIONATE AND TAZAROTENE

LOTION;TOPICAL; 0.01%;0.045%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DUOBRII	HALOBETASOL PROPIONATE; TAZAROTENE	0.01%;0.045%	LOTION;TOPICAL	Prescription	Yes	AB	209354	BAUSCH
HALOBETASOL PROPIONATE AND TAZAROTENE	HALOBETASOL PROPIONATE; TAZAROTENE	0.01%;0.045%	LOTION;TOPICAL	Prescription	No	AB	217190	SUN PHARMA CANADA