Home Applications 214965 Application 214965
Type NDA
Sponsor SANTEN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VERKAZIA CYCLOSPORINE EMULSION; OPHTHALMIC 0.1% Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N214965-001 VERKAZIA CYCLOSPORINE 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214965-001 11612658 2026-01-27 U-3560 2023-04-25 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 N214965-001 9132071 2029-06-02 Drug product 2021-07-15
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214965-001 ODE-358 2028-06-23
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.
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 2026-02-19 14:30 UTC 2026-02 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 220 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 60 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65086-001 Verkazia cyclosporine Santen Incorporated NDA Current 65086-001 Verkazia cyclosporine Santen Incorporated NDA Current 65086-001 Verkazia cyclosporine Santen Incorporated NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 70961 ORIG 2022-05-04 67912 ORIG 2021-06-28 67888 ORIG 2021-06-24