Flurandrenolide
Flurandrenolide Cream, USP
Approved
Approval ID
89ff5067-af91-4d28-8ce7-8a86f8a080ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2016
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-5301
Application NumberNDA012806
Product Classification
M
Marketing Category
C73594
G
Generic Name
Flurandrenolide
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2016
FDA Product Classification
INGREDIENTS (9)
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Polyoxyl 40 stearateInactive
Code: 13A4J4NH9I
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sodium Citrate, Unspecified FormInactive
Code: 1Q73Q2JULR
Classification: IACT
Stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
FlurandrenolideActive
Quantity: 0.5 mg in 1 g
Code: 8EUL29XUQT
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT