Home Applications 021994 Application 021994
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRAVATAN Z TRAVOPROST SOLUTION/DROPS;OPHTHALMIC 0.004% 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 N021994-001 TRAVATAN Z TRAVOPROST 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021994-001 AT2
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021994-001 8323630 2027-09-20 Drug product 2012-12-18 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 N021994-001 8268299 2029-10-13 Drug product 2012-09-24
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 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2006-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021994-001 TRAVATAN Z 0.004% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-09-21 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 129 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 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021994-001 8388941 2027-09-20 Drug product 2013-03-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021994-001 8268299 2029-10-13 Drug product 2012-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021994-001 8323630 2027-09-20 Drug product 2012-12-18 301d65b070ca…
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 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0065-0260 Travatan Z travoprost Alcon Laboratories, Inc NDA Current 0065-0260 Travatan Z travoprost Alcon Laboratories, Inc NDA Current 0065-0260 Travatan Z travoprost Alcon Laboratories, Inc NDA Current 0078-0946 Travatan Z travoprost Novartis Pharmaceuticals Corporation NDA Current 0078-0946 Travatan Z travoprost Novartis Pharmaceuticals Corporation NDA Current 0078-0946 Travatan Z travoprost Novartis Pharmaceuticals Corporation NDA Current 0781-6185 Travoprost Ophthalmic Solution travoprost Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-6185 Travoprost Ophthalmic Solution travoprost Sandoz Inc NDA AUTHORIZED GENERIC Current 63629-8839 Travoprost Ophthalmic Solution travoprost Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-8839 Travoprost Ophthalmic Solution travoprost Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-8840 Travoprost Ophthalmic Solution travoprost Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-8840 Travoprost Ophthalmic Solution travoprost Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-8840 Travoprost Ophthalmic Solution travoprost Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 83721 SUPPL 2025-10-10 83719 SUPPL 2025-10-10 62542 SUPPL 2020-04-10 62430 SUPPL 2020-04-03 49864 SUPPL 2017-09-26 49861 SUPPL 2017-09-26 29009 SUPPL 2011-09-12 16715 SUPPL 2011-09-12 38031 SUPPL 2010-09-07 29008 SUPPL 2010-09-02 42373 ORIG 2008-05-07 16714 ORIG 2006-09-25 6626 ORIG 2006-09-25