Home Applications 022212 Application 022212
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DUREZOL DIFLUPREDNATE EMULSION;OPHTHALMIC 0.05% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022212-001 DUREZOL DIFLUPREDNATE 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022212-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC RLD, RS 2008-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC RLD, RS 2008-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC RLD, RS 2008-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC RLD, RS 2008-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC RLD, RS 2008-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC RLD, RS 2008-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC RLD, RS 2008-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC RLD, RS 2008-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022212-001 DUREZOL 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2008-06-23 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022212-001 6114319 2019-05-18 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022212-001 6114319*PED 2019-11-18 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022212-001 6114319 2019-05-18 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022212-001 6114319*PED 2019-11-18 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022212-001 6114319 2019-05-18 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022212-001 6114319*PED 2019-11-18 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022212-001 6114319 2019-05-18 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022212-001 6114319*PED 2019-11-18 Pediatric extension ea99ee380514…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0065-9240 DUREZOL DUREZOL Alcon Laboratories, Inc. NDA Current 0065-9240 DUREZOL DUREZOL Alcon Laboratories, Inc. NDA Current 0065-9240 DUREZOL DUREZOL Alcon Laboratories, Inc. NDA Current 0065-9240 DUREZOL DUREZOL Alcon Laboratories, Inc. NDA Current 0065-9240 DUREZOL DUREZOL Alcon Laboratories, Inc. NDA Current 0078-0862 DUREZOL difluprednate Novartis Pharmaceuticals Corporation NDA Current 0781-6000 DUREZOL Difluprednate Ophthalmic Emulsion Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-6000 Difluprednate Ophthalmic Difluprednate Ophthalmic Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-6000 Difluprednate Ophthalmic Difluprednate Ophthalmic Sandoz Inc NDA AUTHORIZED GENERIC Current