Application 020697

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TASMAR	TOLCAPONE	TABLET;ORAL	100MG	Yes	Yes
002	TASMAR	TOLCAPONE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020697-001	TASMAR	TOLCAPONE	100MG	TABLET / ORAL		RLD, RS	1998-01-29
N020697-002	TASMAR	TOLCAPONE	200MG	TABLET / ORAL			1998-01-29

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N020697-001	TASMAR	100MG	TABLET / ORAL		RLD, RS	1998-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020697-001	TASMAR	100MG	TABLET / ORAL	AB	RLD, RS	1998-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020697-002	TASMAR	200MG	TABLET / ORAL			1998-01-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020697-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020697-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020697-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020697-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020697-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020697-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020697-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020697-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020697-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020697-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020697-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020697-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020697-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020697-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020697-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020697-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020697-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020697-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020697-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020697-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020697-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020697-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020697-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020697-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020697-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020697-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020697-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020697-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020697-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020697-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020697-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020697-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020697-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020697-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020697-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020697-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020697-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020697-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020697-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020697-001	AB	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tasmar	TOLCAPONE	Bausch Health US LLC	a0e47a9d-78e7-4523-983a-aa259f221736	2020-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020697 application number: NDA020697 ndc (product): 0187-0938
Tolcapone	TOLCAPONE	Oceanside Pharmaceuticals	dd367eec-359a-4065-b5c3-7c0107c823fe	2020-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020697 application number: NDA020697 ndc (product): 68682-938

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0938	Tasmar	Tolcapone	Bausch Health US LLC	NDA	Current
0187-0938	Tasmar	Tolcapone	Bausch Health US LLC	NDA	Current
0187-0938	Tasmar	Tolcapone	Valeant Pharmaceuticals North America LLC	NDA	Current
68682-938	Tolcapone	Tolcapone	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-938	Tolcapone	Tolcapone	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
35151	SUPPL	2013-05-14
3096	SUPPL	2013-05-14
3099	SUPPL	2009-07-07
25530	SUPPL	2009-02-13
3098	SUPPL	2009-02-13
13220	SUPPL	2009-02-10
13219	SUPPL	2009-02-10
25529	SUPPL	2007-02-02
13218	SUPPL	2007-01-25
3097	SUPPL	2006-03-01
13217	SUPPL	2006-02-22
20830	ORIG	2002-04-09
35150	ORIG	1998-01-29
3095	ORIG	1998-01-29