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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 211848

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NDA 211848 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 eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the tavaborole profile page.

Summary for 211848

Tradename:	TAVABOROLE
Applicant:	Padagis Us
Ingredient:	tavaborole
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 211848

Mechanism of Action	Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 211848

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211848	ANDA	Padagis US LLC	0574-0157	0574-0157-10	1 BOTTLE, GLASS in 1 CARTON (0574-0157-10) / 10 mL in 1 BOTTLE, GLASS
TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211848	ANDA	Bryant Ranch Prepack	63629-8704	63629-8704-1	1 BOTTLE, GLASS in 1 CARTON (63629-8704-1) / 10 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	5%
Approval Date:	Oct 13, 2020	TE:	AB	RLD:	No

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