Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212383
Company: ENCUBE

Products on ANDA 212383

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 212383

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/13/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212383

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	ALMIRALL
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	209890	AMNEAL
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	218457	AUROBINDO PHARMA LTD
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	SUN PHARMA CANADA
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	213907	TP ANDA HOLDINGS