Application 074260

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

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 43.

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	RLD / RS	Approval date
A074260-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03
A074260-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03
A074260-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074260-001	AB
A074260-002	AB
A074260-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074260-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074260-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074260-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074260-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074260-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074260-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074260-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074260-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074260-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074260-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074260-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074260-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074260-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074260-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074260-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074260-001	AB	1	`301d65b070ca…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	Teva Pharmaceuticals USA, Inc.	4ace5274-b6cf-414c-b9c0-f60e28a9cea5	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	AvKARE	e232e055-7892-3541-e053-2995a90a1e74	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	AvKARE	da471cd4-dcee-b026-e053-2a95a90a3d81	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	AvKARE	11e706c4-433c-1ea6-e063-6294a90ad360	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	American Health Packaging	a62ae74d-6677-459c-b338-00e6851a1e00	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260 ndc (product): 60687-661
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	6d8968a1-0317-464a-bd03-4f683f562de2	2023-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	Aphena Pharma Solutions - Tennessee, LLC	64254508-dbe7-4512-902d-f4a6ef2bfdf8	2022-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260 ndc (product): 71610-664

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 116 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-080	Carbidopa and levodopa	Carbidopa and levodopa	Mayne Pharma Inc.	ANDA	Current
51862-080	Carbidopa and levodopa	Carbidopa and levodopa	Mayne Pharma Inc.	ANDA	Current
51862-080	Carbidopa and levodopa	Carbidopa and levodopa	Mayne Pharma Inc.	ANDA	Current
51862-080	Carbidopa and levodopa	Carbidopa and levodopa	Mayne Pharma Inc.	ANDA	Current
55154-4688	Carbidopa and levodopa	Carbidopa and levodopa	Cardinal Health	ANDA	Current
55154-4688	Carbidopa and levodopa	Carbidopa and levodopa	Cardinal Health	ANDA	Current
55154-7886	Carbidopa and Levodopa	Carbidopa and Levodopa	Cardinal Health	ANDA	Current
55154-7886	Carbidopa and Levodopa	Carbidopa and Levodopa	Cardinal Health	ANDA	Current
55154-7886	Carbidopa and Levodopa	Carbidopa and Levodopa	Cardinal Health 107, LLC	ANDA	Current
55154-7886	Carbidopa and Levodopa	Carbidopa and Levodopa	Cardinal Health	ANDA	Current
55700-642	Carbidopa and levodopa	Carbidopa and levodopa	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60429-152	Carbidopa and levodopa	Carbidopa and levodopa	Golden State Medical Supply, Inc.	ANDA	Current
60429-153	Carbidopa and levodopa	Carbidopa and levodopa	Golden State Medical Supply, Inc.	ANDA	Current
60429-154	Carbidopa and levodopa	Carbidopa and levodopa	Golden State Medical Supply, Inc.	ANDA	Current
60687-661	Carbidopa and Levodopa	Carbidopa and Levodopa	American Health Packaging	ANDA	Current
60687-661	Carbidopa and Levodopa	Carbidopa and Levodopa	American Health Packaging	ANDA	Current
63739-013	Carbidopa and levodopa	Carbidopa and levodopa	McKesson Corporation	ANDA	Current
63739-013	Carbidopa and levodopa	Carbidopa and levodopa	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-017	Carbidopa and levodopa	Carbidopa and levodopa	McKesson Corporation	ANDA	Current
63739-017	Carbidopa and levodopa	Carbidopa and levodopa	McKesson Corporation dba SKY Packaging	ANDA	Current
68084-093	Carbidopa and levodopa	Carbidopa and levodopa	American Health Packaging	ANDA	Current
68084-093	Carbidopa and Levodopa	Carbidopa and Levodopa	American Health Packaging	ANDA	Current
68084-093	Carbidopa and Levodopa	Carbidopa and Levodopa	American Health Packaging	ANDA	Current
68084-093	Carbidopa and Levodopa	Carbidopa and Levodopa	American Health Packaging	ANDA	Current
68084-094	Carbidopa and levodopa	Carbidopa and levodopa	American Health Packaging	ANDA	Current
68084-094	Carbidopa and Levodopa	Carbidopa and Levodopa	American Health Packaging	ANDA	Current
68084-094	Carbidopa and Levodopa	Carbidopa and Levodopa	American Health Packaging	ANDA	Current
68084-094	Carbidopa and Levodopa	Carbidopa and Levodopa	American Health Packaging	ANDA	Current
70518-2908	Carbidopa and levodopa	Carbidopa and levodopa	REMEDYREPACK INC.	ANDA	Current
70518-2908	Carbidopa and levodopa	Carbidopa and levodopa	REMEDYREPACK INC.	ANDA	Current
70518-2909	Carbidopa and levodopa	Carbidopa and levodopa	REMEDYREPACK INC.	ANDA	Current
70518-2909	Carbidopa and levodopa	Carbidopa and levodopa	REMEDYREPACK INC.	ANDA	Current
70518-2909	Carbidopa and levodopa	Carbidopa and levodopa	REMEDYREPACK INC.	ANDA	Current
71610-579	Carbidopa and levodopa	Carbidopa and levodopa	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-664	Carbidopa and levodopa	Carbidopa and levodopa	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-664	Carbidopa and levodopa	Carbidopa and levodopa	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current