Application 021994

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAVATAN ZTRAVOPROSTSOLUTION/DROPS;OPHTHALMIC0.004%YesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021994-001TRAVATAN ZTRAVOPROST0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021994-001AT2

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021994-00183236302027-09-20Drug product2012-12-18
N021994-00183889412027-09-20Drug product2013-03-08
N021994-00182682992029-10-13Drug product2012-09-24

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICAT2RLD, RS2006-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021994-001TRAVATAN Z0.004%SOLUTION/DROPS / OPHTHALMICATRLD, RS2006-09-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021994-001AT21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-001AT2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021994-001AT216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-001AT21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021994-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021994-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021994-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021994-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021994-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021994-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021994-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021994-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021994-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N021994-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021994-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021994-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021994-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N021994-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021994-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021994-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021994-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021994-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021994-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021994-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021994-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021994-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021994-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021994-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021994-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021994-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021994-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021994-001AT1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021994-00183236302027-09-20Drug product2012-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021994-00183889412027-09-20Drug product2013-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021994-00182682992029-10-13Drug product2012-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-00183236302027-09-20Drug product2012-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-00183889412027-09-20Drug product2013-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021994-00182682992029-10-13Drug product2012-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021994-00183236302027-09-20Drug product2012-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021994-00183889412027-09-20Drug product2013-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021994-00182682992029-10-13Drug product2012-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-00183236302027-09-20Drug product2012-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-00183889412027-09-20Drug product2013-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021994-00182682992029-10-13Drug product2012-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-00183236302027-09-20Drug product2012-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-00183889412027-09-20Drug product2013-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021994-00182682992029-10-13Drug product2012-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-00183236302027-09-20Drug product2012-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-00183889412027-09-20Drug product2013-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021994-00182682992029-10-13Drug product2012-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-00183236302027-09-20Drug product2012-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-00183889412027-09-20Drug product2013-03-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021994-00182682992029-10-13Drug product2012-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-00183236302027-09-20Drug product2012-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-00183889412027-09-20Drug product2013-03-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021994-00182682992029-10-13Drug product2012-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-00183236302027-09-20Drug product2012-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-00183889412027-09-20Drug product2013-03-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021994-00182682992029-10-13Drug product2012-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021994-00183236302027-09-20Drug product2012-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N021994-00183889412027-09-20Drug product2013-03-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N021994-00182682992029-10-13Drug product2012-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-00183236302027-09-20Drug product2012-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-00183889412027-09-20Drug product2013-03-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021994-00182682992029-10-13Drug product2012-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-00183236302027-09-20Drug product2012-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-00183889412027-09-20Drug product2013-03-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021994-00182682992029-10-13Drug product2012-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-00183236302027-09-20Drug product2012-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-00183889412027-09-20Drug product2013-03-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021994-00182682992029-10-13Drug product2012-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021994-00183236302027-09-20Drug product2012-12-188072bd15b7f6…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Travatan ZTRAVOPROSTSandoz Inc4b5cffb0-74e0-44e4-8e18-f5d56e9db4502025-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 021994
application number: NDA021994
Travatan ZTRAVOPROSTNovartis Pharmaceuticals Corporation028455e0-ae77-4213-8819-3b58ef7d6a142023-06-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 021994
application number: NDA021994
ndc (product): 0078-0946

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0260Travatan ZtravoprostAlcon Laboratories, IncNDACurrent
0065-0260Travatan ZtravoprostAlcon Laboratories, IncNDACurrent
0065-0260Travatan ZtravoprostAlcon Laboratories, IncNDACurrent
0078-0946Travatan ZtravoprostNovartis Pharmaceuticals CorporationNDACurrent
0078-0946Travatan ZtravoprostNovartis Pharmaceuticals CorporationNDACurrent
0078-0946Travatan ZtravoprostNovartis Pharmaceuticals CorporationNDACurrent
0781-6185Travoprost Ophthalmic SolutiontravoprostSandoz IncNDA AUTHORIZED GENERICCurrent
0781-6185Travoprost Ophthalmic SolutiontravoprostSandoz IncNDA AUTHORIZED GENERICCurrent
63629-8839Travoprost Ophthalmic SolutiontravoprostBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8839Travoprost Ophthalmic SolutiontravoprostBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8840Travoprost Ophthalmic SolutiontravoprostBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8840Travoprost Ophthalmic SolutiontravoprostBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8840Travoprost Ophthalmic SolutiontravoprostBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83721SUPPL 2025-10-10
83719SUPPL 2025-10-10
62542SUPPL2020-04-10
62430SUPPL2020-04-03
49864SUPPL2017-09-26
49861SUPPL2017-09-26
29009SUPPL2011-09-12
16715SUPPL2011-09-12
38031SUPPL2010-09-07
29008SUPPL2010-09-02
42373ORIG2008-05-07
16714ORIG2006-09-25
6626ORIG2006-09-25