ApexiCon E
ApexiCon E Cream(diflorasone diacetate cream USP, 0.05% [emollient])
Approved
Approval ID
41b5193a-08da-4b44-bca5-2b076711c5c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2022
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diflorasone diacetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-365
Application NumberANDA076263
Product Classification
M
Marketing Category
C73584
G
Generic Name
diflorasone diacetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 20, 2022
FDA Product Classification
INGREDIENTS (8)
diflorasone diacetateActive
Quantity: 0.5 mg in 1 g
Code: 7W2J09SCWX
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Sorbitan MonostearateInactive
Code: NVZ4I0H58X
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT