Amcinonide
AMCINONIDE OINTMENT USP, 0.1%
Approved
Approval ID
3a386f5e-530d-446b-a0fb-6b9a667ad23f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2014
Manufacturers
FDA
E. Fougera & Co. a division of 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.
amcinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0279
Application NumberANDA076096
Product Classification
M
Marketing Category
C73584
G
Generic Name
amcinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 1, 2012
FDA Product Classification
INGREDIENTS (7)
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMCINONIDEActive
Quantity: 1 mg in 1 g
Code: 423W026MA9
Classification: ACTIB
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT