NDC 69097-686

TAVABOROLE

Tavaborole

TAVABOROLE is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Tavaborole.

Product ID69097-686_ac0a7dcc-4cd8-412b-8238-bbc23aa5cdc6
NDC69097-686
Product TypeHuman Prescription Drug
Proprietary NameTAVABOROLE
Generic NameTavaborole
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2021-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA212224
Labeler NameCipla USA 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 69097-686-34

1 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-34) > 4 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date2021-02-18
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.