NDC 51672-1397

TAVABOROLE

Tavaborole

TAVABOROLE is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Taro Pharmaceuticals U.s.a., Inc.. The primary component is Tavaborole.

Product ID51672-1397_34940f27-ae26-41f3-9544-bd9d500fa85c
NDC51672-1397
Product TypeHuman Prescription Drug
Proprietary NameTAVABOROLE
Generic NameTavaborole
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2021-05-07
Marketing CategoryANDA /
Application NumberANDA212215
Labeler NameTaro Pharmaceuticals U.S.A., Inc.
Substance NameTAVABOROLE
Active Ingredient Strength44 mg/mL
Pharm ClassesOxaborole Antifungal [EPC],Protein Synthesis Inhibitors [MoA],Boron Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 51672-1397-9

1 BOTTLE, WITH APPLICATOR in 1 CARTON (51672-1397-9) > 10 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date2021-05-07
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "TAVABOROLE" or generic name "Tavaborole"

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.