Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210191
Company: TARO PHARMS

Products on ANDA 210191

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210191

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210191Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2023	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/27/2023	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210191

DAPSONE

GEL;TOPICAL; 7.5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACZONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	Yes	AB	207154	ALMIRALL
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	215718	ALEMBIC
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	212701	AMNEAL
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	213847	MYLAN
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	210191	TARO PHARMS
DAPSONE	DAPSONE	7.5%	GEL;TOPICAL	Prescription	No	AB	214722	TORRENT