Flurandrenolide
FLURANDRENOLIDE OINTMENT USP, 0.05%
Approved
Approval ID
14709d5d-186c-41f1-a7cc-e08872ad6e28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2016
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
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 Code52565-017
Application NumberANDA207851
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flurandrenolide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 10, 2019
FDA Product Classification
INGREDIENTS (5)
White WaxInactive
Code: 7G1J5DA97F
Classification: IACT
FlurandrenolideActive
Quantity: 0.5 mg in 1 g
Code: 8EUL29XUQT
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Sorbitan SesquioleateInactive
Code: 0W8RRI5W5A
Classification: IACT
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT