NDC 0078-0862

DUREZOL

Difluprednate

DUREZOL is a Ophthalmic Emulsion in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Difluprednate.

Product ID0078-0862_830dd64e-8b1a-4bc4-86bd-e0a0915b59e7
NDC0078-0862
Product TypeHuman Prescription Drug
Proprietary NameDUREZOL
Generic NameDifluprednate
Dosage FormEmulsion
Route of AdministrationOPHTHALMIC
Marketing Start Date2011-01-25
Marketing CategoryNDA /
Application NumberNDA022212
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameDIFLUPREDNATE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0078-0862-25

1 BOTTLE in 1 CARTON (0078-0862-25) > 5 mL in 1 BOTTLE
Marketing Start Date2022-07-05
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "DUREZOL" or generic name "Difluprednate"

NDCBrand NameGeneric Name
0065-9240DUREZOLDUREZOL
0078-0862DUREZOLdifluprednate
0781-6000DUREZOLDifluprednate Ophthalmic Emulsion
69097-341DIFLUPREDNATEDIFLUPREDNATE
76282-708DIFLUPREDNATEDIFLUPREDNATE

Trademark Results [DUREZOL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DUREZOL
DUREZOL
77830018 3784208 Live/Registered
NOVARTIS AG
2009-09-18
DUREZOL
DUREZOL
77340065 not registered Dead/Abandoned
Sirion Therapeutics, Inc.
2007-11-29

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