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 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	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090631-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090631-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090631-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-06-08	`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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	3b06a0e2-bec8-4178-942b-67eb47f2916e	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Bryant Ranch Prepack	043e58c6-092d-4637-90f1-9d36af143a24	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Coupler LLC	5682a705-de0e-6b70-e063-6394a90aadfb	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Aphena Pharma Solutions - Tennessee, LLC	5644d10f-620e-810e-e063-6294a90af678	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: CARBIDOPA AND LEVODOPA
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	Teva Pharmaceuticals USA, Inc.	4ace5274-b6cf-414c-b9c0-f60e28a9cea5	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	AvPAK	54f30abc-97fa-00f0-e063-6394a90a155d	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Radha Pharmaceuticals Inc	33a22ffe-0d41-162d-e063-6394a90a43d3	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	48e0f2ec-b217-4c25-a71c-20e173d05edb	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: CARBIDOPA AND LEVODOPA
CARBIDOPA AND LEVODOPA	CARBIDOPA AND LEVODOPA	Sun Pharmaceutical Industries, Inc.	d2a64f14-f638-49d9-8a96-cb7ae46ac3ea	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: CARBIDOPA AND LEVODOPA
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	ScieGen Pharmaceuticals Inc	1b17ab1e-f3c1-4343-ba28-e2901cd97d43	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Major Pharmaceuticals	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Westminster Pharmaceuticals, LLC	3f026272-32a6-4c98-8b6f-d910c7f58aa2	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Dr. Reddy's Laboratories Inc	87ab55c9-203d-d595-3e3e-0e38f2f6d9c4	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	Advagen Pharma Ltd	5b6519ff-d1af-402b-83eb-b4fce6743a18	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	4ce99f65-5857-448c-b22a-9b3b64de69e2	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	ScieGen Pharmaceuticals Inc	a32afa84-7bc0-4bd3-bc50-55d738f3d7ce	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Mylan Pharmaceuticals Inc.	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	b29e58f0-67b1-4036-a4a8-4915a8c13cdf	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	beedd327-bbc5-4f17-838a-4e72bf0867f0	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	REMEDYREPACK INC.	57688b2c-7be0-4e73-9b4f-7ec3b5dc1c37	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Carbidopa and Levodopa

Application 090631

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#