Application 021257

Type: NDA
Sponsor: ALCON PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAVATAN	TRAVOPROST	SOLUTION/DROPS;OPHTHALMIC	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N021257-001	TRAVATAN	TRAVOPROST	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2001-03-16

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021257-001	TRAVATAN	0.004%	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021257-001	TRAVATAN	0.004%	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021257-001	TRAVATAN	0.004% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2001-03-16	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Travoprost	TRAVOPROST	Golden State Medical Supply, Inc.	efe2861a-f7ca-ae06-e053-2995a90a50e9	2025-11-21	Warnings, Adverse reactions	Name fallback generic name: TRAVOPROST
Travoprost	TRAVOPROST	Apotex Corp.	98fb77b8-ee41-e2fc-7bcd-bc350e19cc10	2025-11-14	Warnings, Adverse reactions	Name fallback generic name: TRAVOPROST
Travoprost Ophthalmic Soluton	TRAVOPROST	Sagent Pharmaceuticals	498a376e-a74e-48d8-a022-ad15a1ecadb5	2025-06-07	Warnings, Adverse reactions	Name fallback generic name: TRAVOPROST
Travatan Z	TRAVOPROST	Sandoz Inc	4b5cffb0-74e0-44e4-8e18-f5d56e9db450	2025-01-31	Warnings, Adverse reactions	Name fallback generic name: TRAVOPROST
Travatan Z	TRAVOPROST	Novartis Pharmaceuticals Corporation	028455e0-ae77-4213-8819-3b58ef7d6a14	2023-06-27	Warnings, Adverse reactions	Name fallback generic name: TRAVOPROST

Documents#

Document, Submission type, Date table
Document	Submission type	Date
36486	SUPPL	2011-09-12
4805	SUPPL	2011-09-12
36485	SUPPL	2010-09-07
4804	SUPPL	2010-09-02
27239	SUPPL	2006-01-30
4803	SUPPL	2006-01-30
36484	SUPPL	2006-01-27
14769	SUPPL	2006-01-27
27233	ORIG	2004-06-28
36483	SUPPL	2004-03-03
14768	SUPPL	2004-03-03
27238	SUPPL	2004-02-27
4802	SUPPL	2004-02-27
27237	SUPPL	2003-06-08
14767	SUPPL	2003-05-29
36482	SUPPL	2003-03-05
27236	SUPPL	2003-02-13
27235	SUPPL	2003-02-13
27234	SUPPL	2003-02-13
14766	SUPPL	2003-02-13
14765	SUPPL	2003-02-13
42057	ORIG	2001-08-20
14764	ORIG	2001-03-16