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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211963

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NDA 211963 describes TAVABOROLE, which is a drug marketed by Alembic, Amneal, Chartwell Rx, Cipla, Encube, Lupin Ltd, Padagis Us, Taro, and Zydus Lifesciences, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the TAVABOROLE profile page.

The generic ingredient in TAVABOROLE is tavaborole. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tavaborole profile page.

Summary for 211963

Tradename:	TAVABOROLE
Applicant:	Chartwell Rx
Ingredient:	tavaborole
Patents:	0

Pharmacology for NDA: 211963

Mechanism of Action	Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 211963

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211963	ANDA	Chartwell RX, LLC	62135-663	62135-663-59	10 mL in 1 BOTTLE, DROPPER (62135-663-59)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	5%
Approval Date:	Feb 3, 2021	TE:	AB	RLD:	No

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