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Diflorasone Diacetate

Diflorasone Diacetate Ointment USP, 0.05%

Approved
Approval ID

0705869c-b801-4477-b8fe-e06b1cd37352

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 23, 2019

Manufacturers
FDA

Innovida Pharmaceutique Corporation

DUNS: 080892908

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 Code71800-009
Application NumberANDA075331
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diflorasone Diacetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 17, 2018
FDA Product Classification

INGREDIENTS (4)

petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
Diflorasone DiacetateActive
Quantity: 0.5 mg in 1 g
Code: 7W2J09SCWX
Classification: ACTIB
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT

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Diflorasone Diacetate - FDA Drug Approval Details