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 ID | 0781-6000_0f60b857-7898-4a9e-935c-a9ddf0eb9194 |
| NDC | 0781-6000 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DUREZOL |
| Generic Name | Difluprednate Ophthalmic Emulsion |
| Dosage Form | Emulsion |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2013-05-15 |
| Marketing Category | NDA AUTHORIZED GENERIC / |
| Application Number | NDA022212 |
| Labeler Name | Sandoz Inc |
| Substance Name | DIFLUPREDNATE |
| Active Ingredient Strength | 1 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-09-15 |
| 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 |
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 |