Application 090324

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET;ORAL10MG;100MGNoNo
002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET;ORAL25MG;100MGNoNo
003CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPATABLET;ORAL25MG;250MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090324-001CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA10MG;100MGTABLET / ORAL2009-09-28
A090324-002CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28
A090324-003CARBIDOPA AND LEVODOPACARBIDOPA; LEVODOPA25MG;250MGTABLET / ORAL2009-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090324-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-2884e616aacf4f…
2026-08-18 06:07:402026-07A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORAL2009-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORAL2009-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-002CARBIDOPA AND LEVODOPA25MG;100MGTABLET / ORALAB2009-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-003CARBIDOPA AND LEVODOPA25MG;250MGTABLET / ORALAB2009-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090324-001CARBIDOPA AND LEVODOPA10MG;100MGTABLET / ORALAB2009-09-28301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090324-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090324-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090324-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090324-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090324-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090324-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090324-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090324-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090324-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090324-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090324-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090324-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090324-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090324-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090324-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090324-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090324-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090324-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090324-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090324-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090324-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090324-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090324-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090324-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090324-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090324-002AB15c6f7cd8ea54…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.9ac804f1-7e15-48bc-8ae9-25181a629dd42026-04-24Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPACoupler LLC500f0cdb-10e1-9545-e063-6394a90a3ad12026-04-22Warnings, Adverse reactionsName fallback
brand name: CARBIDOPA AND LEVODOPA
Carbidopa and LevodopaCARBIDOPA AND LEVODOPACardinal Health 107, LLC19d853e2-b8bd-490e-b8d2-b38bec68a1392026-04-16Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAurobindo Pharma Limited4ced8a05-27ac-463f-b331-387e473fdaa12026-04-09Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPAXLCare Pharmaceuticals, Inc.0c630a24-dc51-4601-a5d6-2f9e397a04492026-04-03Warnings, Adverse reactionsName fallback
brand name: CARBIDOPA AND LEVODOPA
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPACamber Pharmaceuticals, Inc.770ba054-fec4-4833-8096-85c3ce3ae8302026-04-01Warnings, Adverse reactionsName fallback
brand name: CARBIDOPA AND LEVODOPA
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAlembic Pharmaceuticals Inc.ac18e5fa-e2ee-4aa5-8d0f-94b63a076e662026-03-30Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAmneal Pharmaceuticals NY LLC0eb24333-3c11-41dd-888d-3a30d3c9d1882026-03-30Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPASafecor Health, LLC015bc056-ee86-4006-ae7c-689b95e566f42026-03-19Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPARising Pharma Holdings, Inc.302bfe03-d222-4a87-80ff-f2dbfb9a07f42026-01-27Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAvKAREe232e055-7892-3541-e053-2995a90a1e742026-01-14Warnings, Adverse reactionsName fallback
brand name: Carbidopa and levodopa
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAvKAREda471cd4-dcee-b026-e053-2a95a90a3d812026-01-14Warnings, Adverse reactionsName fallback
brand name: Carbidopa and levodopa
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAvKARE11e706c4-433c-1ea6-e063-6294a90ad3602026-01-14Warnings, Adverse reactionsName fallback
brand name: Carbidopa and levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPACoupler LLC43ce5061-0830-6f4f-e063-6394a90afc592025-11-17Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAZydus Pharmaceuticals USA Inc.74e7f96b-de31-4e3c-b32d-11421b291d4e2025-11-14Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAmerican Health Packaginga62ae74d-6677-459c-b338-00e6851a1e002025-11-13Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPAAccord Healthcare, Inc.5217a6ec-cc26-4acc-b2da-17f6545c3b602025-10-08Warnings, Adverse reactionsName fallback
brand name: CARBIDOPA AND LEVODOPA
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMylan Institutional Inc.16f9e4d1-6953-4d4f-b4cf-ad95a856ac252025-07-18Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPABryant Ranch Prepack998f805d-da97-484e-a931-e409e8b8c65a2025-04-07Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPACoupler LLC2d9469ba-02b2-0cfc-e063-6394a90a62922025-02-07Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa

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 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0078Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0078Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0078Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0078Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0078Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0085Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0085Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0085Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0085Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-0085Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-1133Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-1133Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-1133Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-1133Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
0378-1133Carbidopa and Levodopacarbidopa and levodopaMylan Pharmaceuticals Inc.ANDACurrent
43353-202Carbidopa and Levodopacarbidopa and levodopaAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-202Carbidopa and Levodopacarbidopa and levodopaAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-884Carbidopa and Levodopacarbidopa and levodopaMylan Institutional Inc.ANDACurrent
51079-884Carbidopa and Levodopacarbidopa and levodopaMylan Institutional Inc.ANDACurrent
60429-650Carbidopa and Levodopacarbidopa and levodopaGolden State Medical Supply, Inc.ANDACurrent
60429-650Carbidopa and Levodopacarbidopa and levodopaGolden State Medical SupplyANDACurrent
60429-650Carbidopa and Levodopacarbidopa and levodopaGolden State Medical SupplyANDACurrent
60429-650Carbidopa and Levodopacarbidopa and levodopaGolden State Medical SupplyANDACurrent
60429-651Carbidopa and Levodopacarbidopa and levodopaGolden State Medical Supply, Inc.ANDACurrent
60429-651Carbidopa and Levodopacarbidopa and levodopaGolden State Medical SupplyANDACurrent
60429-651Carbidopa and Levodopacarbidopa and levodopaGolden State Medical SupplyANDACurrent
60429-651Carbidopa and Levodopacarbidopa and levodopaGolden State Medical SupplyANDACurrent
60429-652Carbidopa and Levodopacarbidopa and levodopaGolden State Medical Supply, Inc.ANDACurrent
60429-652Carbidopa and Levodopacarbidopa and levodopaGolden State Medical SupplyANDACurrent
60429-652Carbidopa and Levodopacarbidopa and levodopaGolden State Medical SupplyANDACurrent
60429-652Carbidopa and Levodopacarbidopa and levodopaGolden State Medical SupplyANDACurrent
68151-2887Carbidopa and Levodopacarbidopa and levodopaCarilion Materials ManagementANDACurrent