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 ID | 0078-0862_830dd64e-8b1a-4bc4-86bd-e0a0915b59e7 |
| NDC | 0078-0862 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DUREZOL |
| Generic Name | Difluprednate |
| Dosage Form | Emulsion |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2011-01-25 |
| Marketing Category | NDA / |
| Application Number | NDA022212 |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | DIFLUPREDNATE |
| Active Ingredient Strength | 1 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-07-05 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0065-9240 | DUREZOL | DUREZOL |
| 0078-0862 | DUREZOL | difluprednate |
| 0781-6000 | DUREZOL | Difluprednate Ophthalmic Emulsion |
| 69097-341 | DIFLUPREDNATE | DIFLUPREDNATE |
| 76282-708 | DIFLUPREDNATE | DIFLUPREDNATE |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DUREZOL 77830018 3784208 Live/Registered |
NOVARTIS AG 2009-09-18 |
![]() DUREZOL 77340065 not registered Dead/Abandoned |
Sirion Therapeutics, Inc. 2007-11-29 |