Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210178
Company: COSETTE

Products on ANDA 210178

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210178

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210178

DAPSONE

GEL;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACZONE	DAPSONE	5%	GEL;TOPICAL	Prescription	Yes	AB	021794	ABBVIE
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	209890	AMNEAL
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	213907	BELOTECA
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	210178	COSETTE
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	212383	ENCUBE
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	209506	TARO