Home Applications 207795 Application 207795
Type NDA
Sponsor BAUSCH AND LOMB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VYZULTA LATANOPROSTENE BUNOD SOLUTION/DROPS;OPHTHALMIC 0.024% 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 N207795-001 VYZULTA LATANOPROSTENE BUNOD 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N207795-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21
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 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 4 · 160 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 79d66fd596c7…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vyzulta LATANOPROSTENE BUNOD Bausch & Lomb Incorporated 60ce7900-a677-4fc2-88d0-1603baa9dbd4 2024-02-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 207795 application number: NDA207795 ndc (product): 24208-504
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 24208-504 Vyzulta latanoprostene bunod Bausch & Lomb Incorporated NDA Current 24208-504 Vyzulta latanoprostene bunod Bausch & Lomb Incorporated NDA Current 24208-504 Vyzulta latanoprostene bunod Bausch & Lomb Incorporated NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 54609 SUPPL 2018-06-19 54597 SUPPL 2018-06-14 50754 ORIG 2017-12-18 50465 ORIG 2017-11-20 50364 ORIG 2017-11-13