Application 078941

Type: ANDA
Sponsor: WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENTACAPONE	ENTACAPONE	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078941-001	ENTACAPONE	ENTACAPONE	200MG	TABLET / ORAL	AB		2012-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078941-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078941-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2012-08-16	`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	A078941-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078941-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078941-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078941-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078941-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078941-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078941-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078941-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078941-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078941-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078941-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078941-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078941-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078941-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078941-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078941-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078941-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078941-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078941-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078941-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078941-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078941-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078941-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078941-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078941-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078941-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078941-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078941-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078941-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078941-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078941-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078941-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078941-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078941-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078941-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078941-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078941-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078941-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078941-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078941-001	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Entacapone	ENTACAPONE	Macleods Pharmaceuticals Limited	56327e32-3b06-4144-91a0-bb1908842e33	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
Entacapone	ENTACAPONE	Rising Pharma Holdings, Inc.	ee02a04a-4b42-4cfa-8d9d-b1459c0ee9fd	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
Entacapone	ENTACAPONE	AvPAK	1fab63f2-9257-6998-5658-7e98db51b184	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
Entacapone	ENTACAPONE	Ajanta Pharma USA Inc.	e9e94e9f-cd7a-45f5-9aeb-9c28ed804d8c	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
Entacapone	ENTACAPONE	Major Pharmaceuticals	863025af-2b71-477d-baa9-3ce7f435e385	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
Entacapone	ENTACAPONE	NCS HealthCare of KY, LLC dba Vangard Labs	bff19d15-c57b-4a40-bba4-1e0a85fd09c5	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
Entacapone	ENTACAPONE	American Health Packaging	3d4ec829-7835-4d59-bc5b-6ce38811fba7	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
Entacapone	ENTACAPONE	Aurobindo Pharma Limited	d9cc1327-5474-4136-970a-ec40c41975b2	2024-05-09	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
ENTACAPONE	ENTACAPONE	Alembic Pharmaceuticals Limited	d21ce241-b05a-413e-b19a-249ae42012a8	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: ENTACAPONE generic name: ENTACAPONE
Entacapone	ENTACAPONE	Sandoz Inc	ad4b6d79-efd3-4c43-b4dc-5afdacf939a4	2023-11-30	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
Entacapone	ENTACAPONE	Lannett Company, Inc.	0bf133e4-1c17-4358-9a43-144e6bf2564f	2023-10-07	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
ENTACAPONE	ENTACAPONE	Alembic Pharmaceuticals Inc.	a3782792-75c4-418d-be96-9071df475748	2022-01-06	Warnings, Adverse reactions	Name fallback brand name: ENTACAPONE generic name: ENTACAPONE
Entacapone	ENTACAPONE	Aphena Pharma Solutions - Tennessee, LLC	32d30f97-ae0f-4d02-bdd7-75e0783d66bc	2019-03-14	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE
Entacapone	ENTACAPONE	Sun Pharmaceutical Industries, Inc.	205522fb-bb0e-414e-a413-a08bef727653	2018-10-25	Warnings, Adverse reactions	Name fallback brand name: Entacapone generic name: ENTACAPONE

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
55648-711	Entacapone	Entacapone	Wockhardt Limited	ANDA	Current
64679-711	Entacapone	Entacapone	Wockhardt USA LLC.	ANDA	Current
64679-711	Entacapone	Entacapone	Wockhardt USA LLC.	ANDA	Current
64679-711	Entacapone	Entacapone	Wockhardt USA LLC.	ANDA	Current
64679-711	Entacapone	Entacapone	Wockhardt USA LLC.	ANDA	Current