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FDA Approval

CNL8

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

FDA Approval Summary

Company
Innocutis Holdings LLC
DUNS: 071501252
Effective Date
December 1, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ciclopirox(2.28 g in 1 mL)

Products1

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

CNL8

Product Details

NDC Product Code
68712-027
Application Number
ANDA078270
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
December 1, 2011
Code: 19W019ZDRJClass: ACTIBQuantity: 2.28 g in 1 mL
ETHYL ACETATEInactive
Code: 76845O8NMZClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
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