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FDA Approval

Tavaborole

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Padagis US LLC
DUNS: 967694121
Effective Date
November 15, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tavaborole(43.5 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tavaborole

Product Details

NDC Product Code
0574-0157
Application Number
ANDA211848
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
January 11, 2021
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
Code: K124A4EUQ3Class: ACTIBQuantity: 43.5 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
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