NDC 21922-020

Tavaborole

Tavaborole Topical Solution, 5%

Tavaborole is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Encube Ethicals Private Limited. The primary component is Tavaborole.

Product ID21922-020_b2cb2744-3046-29c4-e053-2995a90aa87c
NDC21922-020
Product TypeHuman Prescription Drug
Proprietary NameTavaborole
Generic NameTavaborole Topical Solution, 5%
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2020-10-19
Marketing CategoryANDA / ANDA
Application NumberANDA211297
Labeler NameEncube Ethicals Private Limited
Substance NameTAVABOROLE
Active Ingredient Strength44 mg/mL
Pharm ClassesOxaborole Antifungal [EPC],Protein Synthesis Inhibitors [MoA],Boron Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 21922-020-12

1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-020-12) > 10 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date2020-10-19
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Tavaborole" or generic name "Tavaborole Topical Solution, 5%"

NDCBrand NameGeneric Name
0574-0157TavaboroleTavaborole
21922-020TavaboroleTAVABOROLE topical solution, 5%
51672-1397TAVABOROLETAVABOROLE
51862-690tavaboroletavaborole
62332-467TavaboroleTavaborole
63629-8704TavaboroleTavaborole
68180-958TavaboroleTavaborole
69097-686TAVABOROLETAVABOROLE
69238-1657TavaboroleTavaborole
71589-010TAVABOROLETAVABOROLE
72763-201TavaboroleTavaborole
10337-905KerydinTavaborole

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.