Fluocinolone Acetonide
FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%
Approved
Approval ID
5649e15a-6a7c-4752-ac28-01e453afb37e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2021
Manufacturers
FDA
Fougera Pharmaceuticals Inc.
DUNS: 043838424
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluocinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0059
Application NumberANDA088167
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 8, 2017
FDA Product Classification
INGREDIENTS (3)
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
fluocinolone acetonideActive
Quantity: 0.1 mg in 1 mL
Code: 0CD5FD6S2M
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT