Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209506
Company: TARO

Products on ANDA 209506

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 209506

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2017	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209506Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209506Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 209506

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209506Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 209506

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	210178	COSETTE
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	212383	ENCUBE
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	209506	TARO
DAPSONE	DAPSONE	5%	GEL;TOPICAL	Prescription	No	AB	213907	TRUPHARMA