Application 214092

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET;ORAL	10MG;100MG	No	No
002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET;ORAL	25MG;100MG	No	No
003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET;ORAL	25MG;250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214092-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07
A214092-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07
A214092-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214092-001	AB
A214092-002	AB
A214092-003	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 3 · 99 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
2026-02-19 14:30 UTC	2026-02	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214092-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214092-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214092-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214092-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214092-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214092-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214092-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214092-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214092-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214092-001	AB	1	`8072bd15b7f6…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Westminster Pharmaceuticals, LLC	3f026272-32a6-4c98-8b6f-d910c7f58aa2	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092 ndc (product): 69367-339 ndc (product): 69367-338 ndc (product): 69367-340
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	ScieGen Pharmaceuticals Inc	a32afa84-7bc0-4bd3-bc50-55d738f3d7ce	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092 ndc (product): 50228-457 ndc (product): 50228-458 ndc (product): 50228-459
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Coupler LLC	2d9469ba-02b2-0cfc-e063-6394a90a6292	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	f207467e-ac62-446a-b42e-371efd0c7b2b	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092 ndc (product): 50090-5969
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	7219022c-a56a-4501-9437-601f6cb34e6b	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	84831a49-02d8-421e-8f05-f1358d7149cb	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	08f51366-0a54-48f5-8f10-940745850325	2023-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Aphena Pharma Solutions - Tennessee, LLC	289ca0b7-1b4f-4653-b329-066447d18c13	2022-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092 ndc (product): 71610-647
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Proficient Rx LP	0215da3f-13a0-400d-ac2d-20c839bd89ef	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092 ndc (product): 71205-878 ndc (product): 71205-879 ndc (product): 71205-877

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5969	Carbidopa and Levodopa	Carbidopa and Levodopa	A-S Medication Solutions	ANDA	Current
50228-457	Carbidopa and Levodopa	Carbidopa and Levodopa	ScieGen Pharmaceuticals Inc	ANDA	Current
50228-457	Carbidopa and Levodopa	Carbidopa and Levodopa	ScieGen Pharmaceuticals Inc	ANDA	Current
50228-458	Carbidopa and Levodopa	Carbidopa and Levodopa	ScieGen Pharmaceuticals Inc	ANDA	Current
50228-458	Carbidopa and Levodopa	Carbidopa and Levodopa	ScieGen Pharmaceuticals Inc	ANDA	Current
50228-459	Carbidopa and Levodopa	Carbidopa and Levodopa	ScieGen Pharmaceuticals Inc	ANDA	Current
50228-459	Carbidopa and Levodopa	Carbidopa and Levodopa	ScieGen Pharmaceuticals Inc	ANDA	Current
69367-338	Carbidopa and Levodopa	Carbidopa and Levodopa	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-339	Carbidopa and Levodopa	Carbidopa and Levodopa	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-340	Carbidopa and Levodopa	Carbidopa and Levodopa	Westminster Pharmaceuticals, LLC	ANDA	Current
70518-3250	Carbidopa and Levodopa	Carbidopa and Levodopa	REMEDYREPACK INC.	ANDA	Current
71205-877	Carbidopa and Levodopa	Carbidopa and Levodopa	Proficient Rx LP	ANDA	Current
71205-877	Carbidopa and Levodopa	Carbidopa and Levodopa	Proficient Rx LP	ANDA	Current
71205-878	Carbidopa and Levodopa	Carbidopa and Levodopa	Proficient Rx LP	ANDA	Current
71205-878	Carbidopa and Levodopa	Carbidopa and Levodopa	Proficient Rx LP	ANDA	Current
71205-879	Carbidopa and Levodopa	Carbidopa and Levodopa	Proficient Rx LP	ANDA	Current
71205-879	Carbidopa and Levodopa	Carbidopa and Levodopa	Proficient Rx LP	ANDA	Current
71610-647	Carbidopa and Levodopa	Carbidopa and Levodopa	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current