Application 219989
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | CARBIDOPA AND LEVODOPA | CARBIDOPA, LEVODOPA | CAPSULE, EXTENDED RELEASE | 140MG | No | No |
| 003 | CARBIDOPA AND LEVODOPA | CARBIDOPA, LEVODOPA | CAPSULE, EXTENDED RELEASE | 87.5MG | No | No |
| 004 | CARBIDOPA AND LEVODOPA | CARBIDOPA, LEVODOPA | CAPSULE, EXTENDED RELEASE | 350MG | No | No |
| 005 | CARBIDOPA AND LEVODOPA | CARBIDOPA, LEVODOPA | CAPSULE, EXTENDED RELEASE | 70MG | No | No |
| 006 | CARBIDOPA AND LEVODOPA | CARBIDOPA, LEVODOPA | CAPSULE, EXTENDED RELEASE | 280MG | No | No |
| 007 | CARBIDOPA AND LEVODOPA | CARBIDOPA, LEVODOPA | CAPSULE, EXTENDED RELEASE | 52.5MG | No | No |
| 008 | CARBIDOPA AND LEVODOPA | CARBIDOPA, LEVODOPA | CAPSULE, EXTENDED RELEASE | 210MG | No | No |
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 | REMEDYREPACK INC. | 9ac804f1-7e15-48bc-8ae9-25181a629dd4 | 2026-04-24 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | Coupler LLC | 500f0cdb-10e1-9545-e063-6394a90a3ad1 | 2026-04-22 | Warnings, Adverse reactions | CARBIDOPA AND LEVODOPA |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Cardinal Health 107, LLC | 19d853e2-b8bd-490e-b8d2-b38bec68a139 | 2026-04-16 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Aurobindo Pharma Limited | 4ced8a05-27ac-463f-b331-387e473fdaa1 | 2026-04-09 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | XLCare Pharmaceuticals, Inc. | 0c630a24-dc51-4601-a5d6-2f9e397a0449 | 2026-04-03 | Warnings, Adverse reactions | CARBIDOPA AND LEVODOPA |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | Camber Pharmaceuticals, Inc. | 770ba054-fec4-4833-8096-85c3ce3ae830 | 2026-04-01 | Warnings, Adverse reactions | CARBIDOPA AND LEVODOPA |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Alembic Pharmaceuticals Inc. | ac18e5fa-e2ee-4aa5-8d0f-94b63a076e66 | 2026-03-30 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Amneal Pharmaceuticals NY LLC | 0eb24333-3c11-41dd-888d-3a30d3c9d188 | 2026-03-30 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Safecor Health, LLC | 015bc056-ee86-4006-ae7c-689b95e566f4 | 2026-03-19 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Rising Pharma Holdings, Inc. | 302bfe03-d222-4a87-80ff-f2dbfb9a07f4 | 2026-01-27 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and levodopa | CARBIDOPA AND LEVODOPA | AvKARE | e232e055-7892-3541-e053-2995a90a1e74 | 2026-01-14 | Warnings, Adverse reactions | Carbidopa and levodopa |
| Carbidopa and levodopa | CARBIDOPA AND LEVODOPA | AvKARE | da471cd4-dcee-b026-e053-2a95a90a3d81 | 2026-01-14 | Warnings, Adverse reactions | Carbidopa and levodopa |
| Carbidopa and levodopa | CARBIDOPA AND LEVODOPA | AvKARE | 11e706c4-433c-1ea6-e063-6294a90ad360 | 2026-01-14 | Warnings, Adverse reactions | Carbidopa and levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Coupler LLC | 43ce5061-0830-6f4f-e063-6394a90afc59 | 2025-11-17 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Zydus Pharmaceuticals USA Inc. | 74e7f96b-de31-4e3c-b32d-11421b291d4e | 2025-11-14 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | American Health Packaging | a62ae74d-6677-459c-b338-00e6851a1e00 | 2025-11-13 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| CARBIDOPA AND LEVODOPA | CARBIDOPA AND LEVODOPA | Accord Healthcare, Inc. | 5217a6ec-cc26-4acc-b2da-17f6545c3b60 | 2025-10-08 | Warnings, Adverse reactions | CARBIDOPA AND LEVODOPA |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Mylan Institutional Inc. | 16f9e4d1-6953-4d4f-b4cf-ad95a856ac25 | 2025-07-18 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Bryant Ranch Prepack | 998f805d-da97-484e-a931-e409e8b8c65a | 2025-04-07 | Warnings, Adverse reactions | Carbidopa and Levodopa |
| Carbidopa and Levodopa | CARBIDOPA AND LEVODOPA | Coupler LLC | 2d9469ba-02b2-0cfc-e063-6394a90a6292 | 2025-02-07 | Warnings, Adverse reactions | Carbidopa and Levodopa |