NDC 0781-6000

DUREZOL

Difluprednate Ophthalmic Emulsion

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

Product ID0781-6000_0f60b857-7898-4a9e-935c-a9ddf0eb9194
NDC0781-6000
Product TypeHuman Prescription Drug
Proprietary NameDUREZOL
Generic NameDifluprednate Ophthalmic Emulsion
Dosage FormEmulsion
Route of AdministrationOPHTHALMIC
Marketing Start Date2013-05-15
Marketing CategoryNDA AUTHORIZED GENERIC /
Application NumberNDA022212
Labeler NameSandoz Inc
Substance NameDIFLUPREDNATE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0781-6000-78

1 BOTTLE in 1 CARTON (0781-6000-78) > 5 mL in 1 BOTTLE
Marketing Start Date2021-09-15
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0065-9240DUREZOLDUREZOL
0078-0862DUREZOLdifluprednate
0781-6000DUREZOLDifluprednate Ophthalmic Emulsion

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.