Ciclopirox Olamine
Ciclopirox Olamine 0.77% Cream
Approved
Approval ID
f186e394-7390-4b8a-e053-2a95a90abed1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2023
Manufacturers
FDA
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ciclopirox Olamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80425-0225
Application NumberANDA090273
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciclopirox Olamine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 9, 2023
FDA Product Classification
INGREDIENTS (1)
CICLOPIROX OLAMINEActive
Quantity: 7.7 mg in 1 g
Code: 50MD4SB4AP
Classification: ACTIM