TAVABOROLE - tavaborole solution 
Zydus Lifesciences Limited

----------

Tavaborole Topical Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1826-0

Tavaborole topical solution, 5%

10 mL

Rx only

label
TAVABOROLE 
tavaborole solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1826
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TAVABOROLE (UNII: K124A4EUQ3) (TAVABOROLE - UNII:K124A4EUQ3) TAVABOROLE43.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1826-01 in 1 CARTON04/24/2023
110 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21229404/24/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1826) , MANUFACTURE(70771-1826)

Revised: 4/2023
Document Id: 2dc8a532-94cd-47eb-93d9-d0e1abd6ed57
Set id: 15bc62dc-4f5e-4d43-a125-d1f00bee84a5
Version: 1
Effective Time: 20230412
 
Zydus Lifesciences Limited