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Ciclopirox

Prescribing information

Approved
Approval ID

b281493f-ce8c-42f8-95c7-2eb1c9712157

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 21, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

Ciclopirox

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-6562
Application NumberANDA078172
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 23, 2019
FDA Product Classification

INGREDIENTS (3)

ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
CICLOPIROXActive
Quantity: 80 mg in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT

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Ciclopirox - FDA Drug Approval Details