Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211297
Company: ENCUBE

Products on ANDA 211297

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211297

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/13/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211297Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 211297

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	211963	CHARTWELL RX
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	211297	ENCUBE
TAVABOROLE	TAVABOROLE	5%	SOLUTION;TOPICAL	Prescription	No	AB	212294	ZYDUS LIFESCIENCES