Application 020796

Type: NDA
Sponsor: ORION PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMTAN	ENTACAPONE	TABLET;ORAL	200MG	Yes	Yes

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

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
N020796-001	COMTAN	ENTACAPONE	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020796-001	AB

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 · 42 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	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020796-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020796-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020796-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020796-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020796-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020796-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020796-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020796-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020796-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020796-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020796-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020796-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020796-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020796-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020796-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020796-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020796-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020796-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020796-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020796-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020796-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020796-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020796-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020796-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020796-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020796-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020796-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020796-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020796-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020796-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020796-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020796-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020796-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020796-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020796-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020796-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020796-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020796-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020796-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020796-001	AB	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Entacapone	ENTACAPONE	Sandoz Inc	ad4b6d79-efd3-4c43-b4dc-5afdacf939a4	2023-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020796 application number: NDA020796 ndc (product): 0781-5578
Entacapone	ENTACAPONE	Aphena Pharma Solutions - Tennessee, LLC	32d30f97-ae0f-4d02-bdd7-75e0783d66bc	2019-03-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020796 application number: NDA020796 ndc (product): 71610-247
Entacapone	ENTACAPONE	Sun Pharmaceutical Industries, Inc.	205522fb-bb0e-414e-a413-a08bef727653	2018-10-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020796 application number: NDA020796 ndc (product): 47335-007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0327	Comtan	entacapone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0327	Comtan	entacapone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0327	Comtan	entacapone	Novartis Pharmaceuticals Corporation	NDA	Current
0378-9080	Entacapone	Entacapone	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-9080	Entacapone	Entacapone	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0781-5578	Entacapone	Entacapone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5578	Entacapone	Entacapone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
43353-996	Entacapone	Entacapone	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-996	Entacapone	Entacapone	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
47335-007	Entacapone	Entacapone	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
51079-273	Entacapone	Entacapone	Mylan Institutional Inc.	NDA AUTHORIZED GENERIC	Current
51079-273	Entacapone	Entacapone	Mylan Institutional Inc.	NDA AUTHORIZED GENERIC	Current
51079-273	Entacapone	Entacapone	Mylan Institutional Inc.	NDA AUTHORIZED GENERIC	Current
52427-800	Comtan	entacapone	Almatica Pharma LLC	NDA	Current
52427-800	Comtan	entacapone	Almatica Pharma LLC	NDA	Current
52427-800	Comtan	entacapone	Almatica Pharma LLC	NDA	Current
55648-290	Entacapone	Entacapone	Wockhardt Limited	NDA AUTHORIZED GENERIC	Current
55648-781	Entacapone	Entacapone	Wockhardt Limited	NDA AUTHORIZED GENERIC	Current
64679-290	Entacapone	Entacapone	Wockhardt USA LLC.	NDA AUTHORIZED GENERIC	Current
64679-781	Entacapone	Entacapone	Wockhardt USA LLC.	NDA	Current
64679-781	Entacapone	Entacapone	Wockhardt USA LLC.	NDA	Current
64679-781	Entacapone	Entacapone	Wockhardt USA LLC.	NDA	Current
71610-247	Entacapone	Entacapone	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
13455	SUPPL	2016-02-26
3385	SUPPL	2016-02-24
25858	SUPPL	2015-01-20
13454	SUPPL	2015-01-20
13453	SUPPL	2014-06-17
3384	SUPPL	2014-06-17
3383	SUPPL	2010-10-13
35384	SUPPL	2010-10-11
13452	SUPPL	2009-02-04
13451	SUPPL	2009-02-04
25857	SUPPL	2009-02-03
3382	SUPPL	2009-02-03
25856	ORIG	1999-12-30
20965	ORIG	1999-12-30
13450	ORIG	1999-12-30