Flurandrenolide
Flurandrenolide Lotion USP, 0.05%
Approved
Approval ID
9c4f5aea-2e08-400c-88f6-d9e3013afda7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2022
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flurandrenolide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45802-928
Application NumberANDA207133
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flurandrenolide
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 11, 2022
FDA Product Classification
INGREDIENTS (10)
FLURANDRENOLIDEActive
Quantity: 0.5 mg in 1 mL
Code: 8EUL29XUQT
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT