Application 091340

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAVOPROST	TRAVOPROST	SOLUTION/DROPS;OPHTHALMIC	0.004%	No	Yes

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
A091340-001	TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC		RS	2013-03-01

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC		RS	2013-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC		RS	2013-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC		RS	2013-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC		RS	2013-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC		RS	2013-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC		RS	2013-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC		RS	2013-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC		RS	2013-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091340-001	TRAVOPROST	0.004%	SOLUTION/DROPS / OPHTHALMIC	AT1	RS	2013-03-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091340-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091340-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091340-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091340-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091340-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091340-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091340-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091340-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091340-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091340-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091340-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091340-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091340-001	AT1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A091340-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091340-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091340-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091340-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091340-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091340-001	AT1	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091340-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091340-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091340-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091340-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091340-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091340-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091340-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091340-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091340-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091340-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091340-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091340-001	AT1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091340-001	AT1	1	`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 · 6 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 brand name: Travoprost generic name: TRAVOPROST
Travoprost	TRAVOPROST	Apotex Corp.	98fb77b8-ee41-e2fc-7bcd-bc350e19cc10	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: Travoprost 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
Travoprost	TRAVOPROST (ISOMER FREE)	Somerset Therapeutics, LLC	e9dd2388-afd3-4f40-b35d-54df8c239d29	2024-10-10	Warnings, Adverse reactions	Name fallback brand name: Travoprost
Travatan Z	TRAVOPROST	Novartis Pharmaceuticals Corporation	028455e0-ae77-4213-8819-3b58ef7d6a14	2023-06-27	Warnings, Adverse reactions	Name fallback generic name: TRAVOPROST

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-044	Travoprost Ophthalmic Solution 0.004%	travoprost	Par Pharmaceutical, Inc.	ANDA	Current