Application 090631
- Type
- ANDA
- Sponsor
- IMPAX LABS
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | A-S Medication Solutions | ea1dd532-9fb3-47c2-863c-b288ca7bb24e | 2025-01-22 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | A-S Medication Solutions | 739b2f8d-8b5c-4b57-b5d4-5e6429c7c1ed | 2025-01-22 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | NCS HealthCare of KY, LLC dba Vangard Labs | 45909de3-0852-4e61-8a9e-23f8fcc2463a | 2024-12-06 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | A-S Medication Solutions | f207467e-ac62-446a-b42e-371efd0c7b2b | 2024-10-16 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | A-S Medication Solutions | 7219022c-a56a-4501-9437-601f6cb34e6b | 2024-10-16 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | NCS HealthCare of KY, LLC dba Vangard Labs | ef0be743-e6f3-4662-8b0c-53f1eda4638a | 2024-09-13 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | NuCare Pharmaceuticals,Inc. | ad2ab0c4-188b-f025-e053-2a95a90a2816 | 2024-07-17 | Warnings, Adverse reactions | CARBIDOPA AND LEVODOPA |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | A-S Medication Solutions | 84831a49-02d8-421e-8f05-f1358d7149cb | 2024-06-28 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | Bryant Ranch Prepack | db4198da-7ccc-4283-95ad-74bc98435cac | 2024-01-11 | Warnings, Adverse reactions | CARBIDOPA AND LEVODOPA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | Bryant Ranch Prepack | 7ea16ee0-c429-4b6c-aa67-2d22a934f704 | 2023-12-07 | Warnings, Adverse reactions | CARBIDOPA AND LEVODOPA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | Bryant Ranch Prepack | ff42deb9-56b2-4d9d-8df6-23b9fd4ad66d | 2023-12-07 | Warnings, Adverse reactions | CARBIDOPA AND LEVODOPA |
| Carbidopa and levodopa | CARBIDOPA AND LEVODOPA | A-S Medication Solutions | 6d8968a1-0317-464a-bd03-4f683f562de2 | 2023-10-15 | Warnings, Adverse reactions | Carbidopa and levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | A-S Medication Solutions | 08f51366-0a54-48f5-8f10-940745850325 | 2023-08-09 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and levodopa | CARBIDOPA AND LEVODOPA | Aphena Pharma Solutions - Tennessee, LLC | 64254508-dbe7-4512-902d-f4a6ef2bfdf8 | 2022-10-18 | Warnings, Adverse reactions | Carbidopa and levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Aphena Pharma Solutions - Tennessee, LLC | 289ca0b7-1b4f-4653-b329-066447d18c13 | 2022-05-11 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Proficient Rx LP | 0215da3f-13a0-400d-ac2d-20c839bd89ef | 2022-04-01 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | Sun Pharmaceutical Industries, Inc. | 829c35f9-ace0-11dd-8800-f3e252b43544 | 2021-08-13 | Warnings, Adverse reactions | CARBIDOPA AND LEVODOPA |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Alembic Pharmaceuticals Limited | a85a56c5-44dd-41d4-ac1c-bdc4758406a4 | 2019-06-06 | Warnings, Adverse reactions | Carbidopa and Levodopa |