Label: TAVABOROLE solution
- NDC Code(s): 70771-1826-0
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 12, 2023
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INGREDIENTS AND APPEARANCE
TAVABOROLE
tavaborole solutionProduct 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)
