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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 211297


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NDA 211297 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 211297
Tradename:TAVABOROLE
Applicant:Encube
Ingredient:tavaborole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211297
Mechanism of ActionProtein Synthesis Inhibitors
Suppliers and Packaging for NDA: 211297
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAVABOROLE tavaborole SOLUTION;TOPICAL 211297 ANDA Encube Ethicals Private Limited 21922-020 21922-020-12 1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-020-12) / 10 mL in 1 BOTTLE, WITH APPLICATOR
TAVABOROLE tavaborole SOLUTION;TOPICAL 211297 ANDA Mayne Pharma Commercial LLC 51862-690 51862-690-10 1 BOTTLE, WITH APPLICATOR in 1 CARTON (51862-690-10) / 10 mL in 1 BOTTLE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength5%
Approval Date:Oct 13, 2020TE:ABRLD:No

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