Active ingredient
Difluprednate
11 finished FDA listings contain Difluprednate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DIFLUPREDNATE
- Dosage forms
- Emulsion
- Routes
- Ophthalmic
- Manufacturers / labelers
- 10
- Strengths listed
- .5 mg/ml
- Brand names in FDA listings
- Difluprednate, Difluprednate Ophthalmic Emulsion, Durezol
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 23043
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022212 | SANDOZ | 2008-06-23 | 2 |
| ANDA 211776 | CIPLA | 2021-08-09 | 1 |
| ANDA 211526 | AMNEAL | 2021-11-17 | 1 |
| ANDA 214894 | DR REDDYS | 2022-11-16 | 1 |
| ANDA 219441 | CAPLIN | 2024-12-13 | 2 |
| ANDA 218191 | UPSHER SMITH LABS | 2025-02-11 | 1 |
| ANDA 212566 | MYLAN LABS LTD | 2025-03-20 | 1 |
| ANDA 213774 | ALEMBIC | 2026-01-26 | 2 |
Official labeling on DailyMed
- DIFLUPREDNATE OPHTHALMIC EMULSION [SANDOZ INC] · version 5 · 2026-08-28
- DUREZOL (DIFLUPREDNATE) EMULSION [SANDOZ INC] · version 5 · 2026-08-21
- DIFLUPREDNATE EMULSION [MYLAN PHARMACEUTICALS INC.] · version 4 · 2026-07-24
- DIFLUPREDNATE EMULSION [UPSHER-SMITH LABORATORIES, LLC] · version 7 · 2026-02-19
- DIFLUPREDNATE (DIFLUPREDNATE OPHTHALMIC) EMULSION [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2026-02-02
- DIFLUPREDNATE OPHTHALMIC EMULSION (DIFLUPREDNATE OPHTHALMIC) EMULSION [DR. REDDY'S LABORATORIES INC.] · version 6 · 2025-12-04
- DIFLUPREDNATE EMULSION [LEADING PHARMA, LLC] · version 1 · 2025-02-21
- DIFLUPREDNATE EMULSION [CAPLIN STERILES LIMITED] · version 1 · 2024-12-30
- DIFLUPREDNATE EMULSION [CIPLA USA INC.] · version 1 · 2021-08-16
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.