Application 090631

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET, ORALLY DISINTEGRATING;ORAL	10MG;100MG	No	No
002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET, ORALLY DISINTEGRATING;ORAL	25MG;100MG	No	No
003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET, ORALLY DISINTEGRATING;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	Approval date
A090631-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08
A090631-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08
A090631-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`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 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	9ac804f1-7e15-48bc-8ae9-25181a629dd4	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Coupler LLC	500f0cdb-10e1-9545-e063-6394a90a3ad1	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: CARBIDOPA AND LEVODOPA
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Cardinal Health 107, LLC	19d853e2-b8bd-490e-b8d2-b38bec68a139	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Aurobindo Pharma Limited	4ced8a05-27ac-463f-b331-387e473fdaa1	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	XLCare Pharmaceuticals, Inc.	0c630a24-dc51-4601-a5d6-2f9e397a0449	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: CARBIDOPA AND LEVODOPA
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Camber Pharmaceuticals, Inc.	770ba054-fec4-4833-8096-85c3ce3ae830	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: CARBIDOPA AND LEVODOPA
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Alembic Pharmaceuticals Inc.	ac18e5fa-e2ee-4aa5-8d0f-94b63a076e66	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Amneal Pharmaceuticals NY LLC	0eb24333-3c11-41dd-888d-3a30d3c9d188	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Safecor Health, LLC	015bc056-ee86-4006-ae7c-689b95e566f4	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Rising Pharma Holdings, Inc.	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	AvKARE	e232e055-7892-3541-e053-2995a90a1e74	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and levodopa
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	AvKARE	da471cd4-dcee-b026-e053-2a95a90a3d81	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and levodopa
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	AvKARE	11e706c4-433c-1ea6-e063-6294a90ad360	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Coupler LLC	43ce5061-0830-6f4f-e063-6394a90afc59	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Zydus Pharmaceuticals USA Inc.	74e7f96b-de31-4e3c-b32d-11421b291d4e	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	American Health Packaging	a62ae74d-6677-459c-b338-00e6851a1e00	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Accord Healthcare, Inc.	5217a6ec-cc26-4acc-b2da-17f6545c3b60	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: CARBIDOPA AND LEVODOPA
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Mylan Institutional Inc.	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	998f805d-da97-484e-a931-e409e8b8c65a	2025-04-07	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Coupler LLC	2d9469ba-02b2-0cfc-e063-6394a90a6292	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa

Reported adverse events (FAERS/openFDA)#

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