Prednicarbate
PREDNICARBATE OINTMENT 0.1%
Approved
Approval ID
e6bad712-16df-4f32-a8ea-f8b52e30de00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 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.
prednicarbate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0410
Application NumberANDA077236
Product Classification
M
Marketing Category
C73584
G
Generic Name
prednicarbate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 31, 2021
FDA Product Classification
INGREDIENTS (5)
PREDNICARBATEActive
Quantity: 1.0 mg in 1 g
Code: V901LV1K7D
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERYL MONOOLEATEInactive
Code: C4YAD5F5G6
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT