Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212215
Company: TARO

Products on ANDA 212215

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212215

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/07/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212215Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 212215

TAVABOROLE

SOLUTION;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	212188	ALEMBIC
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	212256	AMNEAL
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	211963	CHARTWELL RX
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	212224	CIPLA
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	211297	ENCUBE
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	212168	LUPIN LTD
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	211848	PADAGIS US
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	212215	TARO
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	212294	ZYDUS LIFESCIENCES