Clotrimazole Topical Solution USP, 1%
Clotrimazole Topical Solution USP, 1%
Approved
Approval ID
1d2354f2-edfd-4be7-9550-760958eb36ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
TruPharma LLC
DUNS: 078533947
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole Topical Solution USP, 1%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52817-800
Application NumberANDA212281
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clotrimazole Topical Solution USP, 1%
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 10, 2019
FDA Product Classification
INGREDIENTS (2)
ClotrimazoleActive
Quantity: 10 mg in 1 mL
Code: G07GZ97H65
Classification: ACTIB
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT