Application 204822

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IZBA	TRAVOPROST	SOLUTION/DROPS;OPHTHALMIC	0.003% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 44.

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
N204822-001	IZBA	TRAVOPROST	0.003% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2014-05-15

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N204822-001	9144561	2029-03-13	Drug product	2015-10-07
N204822-001	8754123	2029-05-19	Drug product	2014-07-15
N204822-001	8178582	2029-10-10	Drug product	2015-08-18
N204822-001	8722735	2029-10-10	Drug product	2014-06-06

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N204822-001	IZBA	0.003% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2014-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204822-001	IZBA	0.003% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2014-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204822-001	IZBA	0.003% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2014-05-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204822-001	IZBA	0.003% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2014-05-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204822-001	9144561	2029-03-13	Drug product	2015-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204822-001	8754123	2029-05-19	Drug product	2014-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204822-001	8178582	2029-10-10	Drug product	2015-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204822-001	8722735	2029-10-10	Drug product	2014-06-06	`2680178bc6a6…`

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 · 4 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 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67764	SUPPL	2021-06-11
67755	SUPPL	2021-06-10
24483	ORIG	2015-06-26
22968	ORIG	2015-06-26
10401	ORIG	2014-05-20
19604	ORIG	2014-05-19