Application 203424
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 12.5MG;200MG;50MG | No | No |
| 002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 18.75MG;200MG;75MG | No | No |
| 003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 25MG;200MG;100MG | No | No |
| 004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 31.25MG;200MG;125MG | No | No |
| 005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 37.5MG;200MG;150MG | No | No |
| 006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | TABLET;ORAL | 50MG;200MG;200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203424-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 12.5MG;200MG;50MG | TABLET / ORAL | 2020-08-13 | ||
| A203424-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 18.75MG;200MG;75MG | TABLET / ORAL | 2020-08-13 | ||
| A203424-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET / ORAL | 2020-08-13 | ||
| A203424-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 31.25MG;200MG;125MG | TABLET / ORAL | 2020-08-13 | ||
| A203424-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET / ORAL | 2020-08-13 | ||
| A203424-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 50MG;200MG;200MG | TABLET / ORAL | 2020-08-13 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203424-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 12.5MG;200MG;50MG | TABLET / ORAL | 2020-08-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203424-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 18.75MG;200MG;75MG | TABLET / ORAL | 2020-08-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203424-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 25MG;200MG;100MG | TABLET / ORAL | 2020-08-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203424-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 31.25MG;200MG;125MG | TABLET / ORAL | 2020-08-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203424-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 37.5MG;200MG;150MG | TABLET / ORAL | 2020-08-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203424-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 50MG;200MG;200MG | TABLET / ORAL | 2020-08-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203424-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 12.5MG;200MG;50MG | TABLET / ORAL | 2020-08-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203424-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 18.75MG;200MG;75MG | TABLET / ORAL | 2020-08-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203424-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 25MG;200MG;100MG | TABLET / ORAL | 2020-08-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203424-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 31.25MG;200MG;125MG | TABLET / ORAL | 2020-08-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203424-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 37.5MG;200MG;150MG | TABLET / ORAL | 2020-08-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203424-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 50MG;200MG;200MG | TABLET / ORAL | 2020-08-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203424-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 12.5MG;200MG;50MG | TABLET / ORAL | 2020-08-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203424-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 18.75MG;200MG;75MG | TABLET / ORAL | 2020-08-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203424-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 25MG;200MG;100MG | TABLET / ORAL | 2020-08-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203424-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 31.25MG;200MG;125MG | TABLET / ORAL | 2020-08-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203424-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 37.5MG;200MG;150MG | TABLET / ORAL | 2020-08-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203424-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 50MG;200MG;200MG | TABLET / ORAL | 2020-08-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203424-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 12.5MG;200MG;50MG | TABLET / ORAL | 2020-08-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203424-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 18.75MG;200MG;75MG | TABLET / ORAL | 2020-08-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203424-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 25MG;200MG;100MG | TABLET / ORAL | 2020-08-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203424-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 31.25MG;200MG;125MG | TABLET / ORAL | 2020-08-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203424-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 37.5MG;200MG;150MG | TABLET / ORAL | 2020-08-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203424-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 50MG;200MG;200MG | TABLET / ORAL | 2020-08-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203424-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 12.5MG;200MG;50MG | TABLET / ORAL | 2020-08-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203424-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 18.75MG;200MG;75MG | TABLET / ORAL | 2020-08-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203424-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 25MG;200MG;100MG | TABLET / ORAL | 2020-08-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203424-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 31.25MG;200MG;125MG | TABLET / ORAL | 2020-08-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203424-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 37.5MG;200MG;150MG | TABLET / ORAL | 2020-08-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203424-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 50MG;200MG;200MG | TABLET / ORAL | 2020-08-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203424-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 12.5MG;200MG;50MG | TABLET / ORAL | 2020-08-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203424-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 18.75MG;200MG;75MG | TABLET / ORAL | 2020-08-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203424-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 25MG;200MG;100MG | TABLET / ORAL | 2020-08-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203424-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 31.25MG;200MG;125MG | TABLET / ORAL | 2020-08-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203424-005 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 37.5MG;200MG;150MG | TABLET / ORAL | 2020-08-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203424-006 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 50MG;200MG;200MG | TABLET / ORAL | 2020-08-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203424-001 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 12.5MG;200MG;50MG | TABLET / ORAL | 2020-08-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203424-002 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 18.75MG;200MG;75MG | TABLET / ORAL | 2020-08-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203424-003 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 25MG;200MG;100MG | TABLET / ORAL | 2020-08-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203424-004 | CARBIDOPA, LEVODOPA AND ENTACAPONE | 31.25MG;200MG;125MG | TABLET / ORAL | 2020-08-13 | b8a1b40f171c… |
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, LEVODOPA AND ENTACAPONE | CARBIDOPA, LEVODOPA AND ENTACAPONE | Rising Pharma Holdings, Inc. | 2f8e82d7-6baf-456a-b8c3-4fda6e317902 | 2026-04-08 | Warnings, Adverse reactions | CARBIDOPA, LEVODOPA AND ENTACAPONE |
| Carbidopa, Levodopa and Entacapone | CARBIDOPA, LEVODOPA AND ENTACAPONE | Macleods Pharmaceuticals Limited | f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b | 2026-04-08 | Warnings, Adverse reactions | Carbidopa, Levodopa and Entacapone |
| carbidopa, levodopa and entacapone | CARBIDOPA, LEVODOPA AND ENTACAPONE | Alembic Pharmaceuticals Inc. | 9d4e886e-edec-471d-b619-bf4828a6b7ce | 2026-03-31 | Warnings, Adverse reactions | carbidopa, levodopa and entacapone |
| carbidopa, levodopa and entacapone | CARBIDOPA, LEVODOPA AND ENTACAPONE | Alembic Pharmaceuticals Limited | 9ff83838-b7d0-4eec-98f2-fcc85789a189 | 2026-02-17 | Warnings, Adverse reactions | carbidopa, levodopa and entacapone |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.