Tavaborole by Zydus Lifesciences Limited TAVABOROLE solution

Tavaborole by

Drug Labeling and Warnings

Tavaborole by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1826-0

Tavaborole topical solution, 5%

10 mL

Rx only

INGREDIENTS AND APPEARANCE

TAVABOROLE 
tavaborole solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1826
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TAVABOROLE (UNII: K124A4EUQ3) (TAVABOROLE - UNII:K124A4EUQ3)	TAVABOROLE	43.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1826-0	1 in 1 CARTON	04/24/2023
1		10 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212294	04/24/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		650650802	ANALYSIS(70771-1826) , MANUFACTURE(70771-1826)