Fluocinolone Acetonide
Fluocinolone Acetonide Topical Solution USP, 0.01% Rx Only
Approved
Approval ID
460f5a55-6437-4651-bc08-8063ca579c8d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 2019
Manufacturers
FDA
Lupin Pharmaceuticals,Inc.
DUNS: 089153071
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 Code43386-069
Application NumberANDA206422
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 21, 2019
FDA Product Classification
INGREDIENTS (3)
FLUOCINOLONE ACETONIDEActive
Quantity: 0.1 mg in 1 mL
Code: 0CD5FD6S2M
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT