Application 216537

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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	Approval date
A216537-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28
A216537-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28
A216537-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216537-001	AB
A216537-002	AB
A216537-003	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 2 · 78 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
2026-09-14 22:38:34	2026-08	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216537-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2022-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216537-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2022-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216537-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2022-11-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A216537-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216537-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216537-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216537-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216537-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216537-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216537-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216537-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216537-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216537-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216537-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216537-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216537-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216537-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216537-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216537-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216537-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216537-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216537-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216537-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216537-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216537-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216537-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216537-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216537-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216537-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216537-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216537-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216537-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216537-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216537-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216537-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216537-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216537-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216537-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216537-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216537-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216537-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216537-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216537-001	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	Coupler LLC	5682a705-de0e-6b70-e063-6394a90aadfb	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216537 application number: ANDA216537
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	57688b2c-7be0-4e73-9b4f-7ec3b5dc1c37	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216537 application number: ANDA216537
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Aurobindo Pharma Limited	4ced8a05-27ac-463f-b331-387e473fdaa1	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216537 application number: ANDA216537 ndc (product): 59651-456 ndc (product): 59651-457 ndc (product): 59651-458
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Coupler LLC	43ce5061-0830-6f4f-e063-6394a90afc59	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216537 application number: ANDA216537
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	998f805d-da97-484e-a931-e409e8b8c65a	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216537 application number: ANDA216537
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	ea1dd532-9fb3-47c2-863c-b288ca7bb24e	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216537 application number: ANDA216537
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	739b2f8d-8b5c-4b57-b5d4-5e6429c7c1ed	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216537 application number: ANDA216537

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 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-456	Carbidopa and Levodopa	Carbidopa and Levodopa	Aurobindo Pharma Limited	ANDA	Current
59651-456	Carbidopa and Levodopa	Carbidopa and Levodopa	Aurobindo Pharma Limited	ANDA	Current
59651-457	Carbidopa and Levodopa	Carbidopa and Levodopa	Aurobindo Pharma Limited	ANDA	Current
59651-457	Carbidopa and Levodopa	Carbidopa and Levodopa	Aurobindo Pharma Limited	ANDA	Current
59651-458	Carbidopa and Levodopa	Carbidopa and Levodopa	Aurobindo Pharma Limited	ANDA	Current
59651-458	Carbidopa and Levodopa	Carbidopa and Levodopa	Aurobindo Pharma Limited	ANDA	Current