Application 217186
- Type
- NDA
- Sponsor
- IMPAX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CREXONT | CARBIDOPA; LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 35MG;140MG | Yes | No |
| 002 | CREXONT | CARBIDOPA; LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 52.5MG;210MG | Yes | No |
| 003 | CREXONT | CARBIDOPA; LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 70MG;280MG | Yes | No |
| 004 | CREXONT | CARBIDOPA; LEVODOPA | CAPSULE, EXTENDED RELEASE;ORAL | 87.5MG;350MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N217186-001 | CREXONT | CARBIDOPA; LEVODOPA | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | |
| N217186-002 | CREXONT | CARBIDOPA; LEVODOPA | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | |
| N217186-003 | CREXONT | CARBIDOPA; LEVODOPA | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | |
| N217186-004 | CREXONT | CARBIDOPA; LEVODOPA | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N217186-001 | 10098845 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-001 | 10292935 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-001 | 10688058 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-001 | 10973769 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-001 | 10987313 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-001 | 11357733 | 2034-10-07 | Drug product | 2024-08-12 | |
| N217186-001 | 11622941 | 2034-10-07 | Drug product | 2024-08-12 | |
| N217186-001 | 11666538 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-001 | 12064521 | 2034-10-07 | Drug product | 2024-08-21 | |
| N217186-001 | 12128141 | 2034-10-07 | U-219 | Drug product | 2024-11-13 |
| N217186-001 | 12178918 | 2034-10-07 | Drug product | 2025-01-08 | |
| N217186-001 | 12178919 | 2034-10-07 | U-219 | Drug product | 2025-01-08 |
| N217186-001 | 12274793 | 2034-10-07 | Drug product | 2025-05-06 | |
| N217186-001 | 12303605 | 2034-10-07 | Drug product | 2025-06-12 | |
| N217186-001 | 12403099 | 2034-10-07 | Drug product | 2025-09-29 | |
| N217186-001 | 12491164 | 2034-10-07 | Drug product | 2026-01-07 | |
| N217186-001 | 11986449 | 2041-12-21 | U-219 | 2024-08-12 | |
| N217186-001 | 12109185 | 2041-12-21 | U-1649 | 2024-10-11 | |
| N217186-001 | 12109185 | 2041-12-21 | U-219 | 2024-10-11 | |
| N217186-001 | 12109185 | 2041-12-21 | U-4004 | 2024-10-11 | |
| N217186-001 | 12109185 | 2041-12-21 | U-4005 | 2024-10-11 | |
| N217186-001 | 12194150 | 2041-12-21 | U-219 | 2025-01-22 | |
| N217186-001 | 12201596 | 2041-12-21 | U-1649 | 2025-02-05 | |
| N217186-001 | 12201596 | 2041-12-21 | U-4004 | 2025-02-05 | |
| N217186-001 | 12201596 | 2041-12-21 | U-4005 | 2025-02-05 | |
| N217186-001 | 12263148 | 2041-12-21 | U-1649 | 2025-04-17 | |
| N217186-001 | 12263148 | 2041-12-21 | U-219 | 2025-04-17 | |
| N217186-001 | 12263148 | 2041-12-21 | U-4004 | 2025-04-17 | |
| N217186-001 | 12263148 | 2041-12-21 | U-4005 | 2025-04-17 | |
| N217186-001 | 12263149 | 2041-12-21 | U-1649 | 2025-04-17 | |
| N217186-001 | 12263149 | 2041-12-21 | U-219 | 2025-04-17 | |
| N217186-001 | 12263149 | 2041-12-21 | U-4004 | 2025-04-17 | |
| N217186-001 | 12263149 | 2041-12-21 | U-4005 | 2025-04-17 | |
| N217186-001 | 12295931 | 2041-12-21 | U-1649 | 2025-06-12 | |
| N217186-001 | 12295931 | 2041-12-21 | U-219 | 2025-06-12 | |
| N217186-001 | 12295931 | 2041-12-21 | U-4004 | 2025-06-12 | |
| N217186-001 | 12295931 | 2041-12-21 | U-4005 | 2025-06-12 | |
| N217186-001 | 12303481 | 2041-12-21 | U-1649 | 2025-06-20 | |
| N217186-001 | 12303481 | 2041-12-21 | U-219 | 2025-06-20 | |
| N217186-001 | 12303481 | 2041-12-21 | U-4004 | 2025-06-20 | |
| N217186-001 | 12303481 | 2041-12-21 | U-4005 | 2025-06-20 | |
| N217186-001 | 12303482 | 2041-12-21 | U-1649 | 2025-06-12 | |
| N217186-001 | 12303482 | 2041-12-21 | U-219 | 2025-06-12 | |
| N217186-001 | 12303482 | 2041-12-21 | U-4004 | 2025-06-12 | |
| N217186-001 | 12303482 | 2041-12-21 | U-4005 | 2025-06-12 | |
| N217186-001 | 12370163 | 2041-12-21 | U-1649 | 2025-08-25 | |
| N217186-001 | 12370163 | 2041-12-21 | U-219 | 2025-08-25 | |
| N217186-001 | 12370163 | 2041-12-21 | U-4004 | 2025-08-25 | |
| N217186-001 | 12370163 | 2041-12-21 | U-4005 | 2025-08-25 | |
| N217186-001 | 12447139 | 2041-12-21 | U-1649 | 2025-11-13 | |
| N217186-001 | 12447139 | 2041-12-21 | U-219 | 2025-11-13 | |
| N217186-001 | 12447139 | 2041-12-21 | U-4004 | 2025-11-13 | |
| N217186-001 | 12447139 | 2041-12-21 | U-4005 | 2025-11-13 | |
| N217186-001 | 12453710 | 2041-12-21 | U-1649 | 2025-11-13 | |
| N217186-001 | 12453710 | 2041-12-21 | U-219 | 2025-11-13 | |
| N217186-001 | 12453710 | 2041-12-21 | U-4004 | 2025-11-13 | |
| N217186-001 | 12453710 | 2041-12-21 | U-4005 | 2025-11-13 | |
| N217186-001 | 12458616 | 2041-12-21 | U-1649 | 2025-11-18 | |
| N217186-001 | 12458616 | 2041-12-21 | U-219 | 2025-11-18 | |
| N217186-001 | 12458616 | 2041-12-21 | U-4004 | 2025-11-18 | |
| N217186-001 | 12458616 | 2041-12-21 | U-4005 | 2025-11-18 | |
| N217186-002 | 10098845 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-002 | 10292935 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-002 | 10688058 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-002 | 10973769 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-002 | 10987313 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-002 | 11357733 | 2034-10-07 | Drug product | 2024-08-12 | |
| N217186-002 | 11622941 | 2034-10-07 | Drug product | 2024-08-12 | |
| N217186-002 | 11666538 | 2034-10-07 | U-219 | Drug product | 2024-08-12 |
| N217186-002 | 12064521 | 2034-10-07 | Drug product | 2024-08-21 | |
| N217186-002 | 12128141 | 2034-10-07 | U-219 | Drug product | 2024-11-13 |
| N217186-002 | 12178918 | 2034-10-07 | Drug product | 2025-01-08 | |
| N217186-002 | 12178919 | 2034-10-07 | U-219 | Drug product | 2025-01-08 |
| N217186-002 | 12274793 | 2034-10-07 | Drug product | 2025-05-06 | |
| N217186-002 | 12303605 | 2034-10-07 | Drug product | 2025-06-12 | |
| N217186-002 | 12403099 | 2034-10-07 | Drug product | 2025-09-29 | |
| N217186-002 | 12491164 | 2034-10-07 | Drug product | 2026-01-07 | |
| N217186-002 | 11986449 | 2041-12-21 | U-219 | 2024-08-12 | |
| N217186-002 | 12109185 | 2041-12-21 | U-1649 | 2024-10-11 | |
| N217186-002 | 12109185 | 2041-12-21 | U-219 | 2024-10-11 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N217186-001 | NP | 2027-08-07 |
| N217186-002 | NP | 2027-08-07 |
| N217186-003 | NP | 2027-08-07 |
| N217186-004 | NP | 2027-08-07 |
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 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N217186-001 | CREXONT | 35MG;140MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N217186-002 | CREXONT | 52.5MG;210MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N217186-003 | CREXONT | 70MG;280MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2024-08-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N217186-004 | CREXONT | 87.5MG;350MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2024-08-07 | d06236e962d9… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 10098845 | 2034-10-07 | U-219 | Drug product | 2024-08-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 10292935 | 2034-10-07 | U-219 | Drug product | 2024-08-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 10688058 | 2034-10-07 | U-219 | Drug product | 2024-08-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 10973769 | 2034-10-07 | U-219 | Drug product | 2024-08-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 10987313 | 2034-10-07 | U-219 | Drug product | 2024-08-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 11357733 | 2034-10-07 | Drug product | 2024-08-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 11622941 | 2034-10-07 | Drug product | 2024-08-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 11666538 | 2034-10-07 | U-219 | Drug product | 2024-08-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12064521 | 2034-10-07 | Drug product | 2024-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12128141 | 2034-10-07 | U-219 | Drug product | 2024-11-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12178918 | 2034-10-07 | Drug product | 2025-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12178919 | 2034-10-07 | U-219 | Drug product | 2025-01-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12274793 | 2034-10-07 | Drug product | 2025-05-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12303605 | 2034-10-07 | Drug product | 2025-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12403099 | 2034-10-07 | Drug product | 2025-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12491164 | 2034-10-07 | Drug product | 2026-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 11986449 | 2041-12-21 | U-219 | 2024-08-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12109185 | 2041-12-21 | U-1649 | 2024-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12109185 | 2041-12-21 | U-219 | 2024-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12109185 | 2041-12-21 | U-4004 | 2024-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12109185 | 2041-12-21 | U-4005 | 2024-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12194150 | 2041-12-21 | U-219 | 2025-01-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12201596 | 2041-12-21 | U-1649 | 2025-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12201596 | 2041-12-21 | U-4004 | 2025-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12201596 | 2041-12-21 | U-4005 | 2025-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12263148 | 2041-12-21 | U-1649 | 2025-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12263148 | 2041-12-21 | U-4004 | 2025-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12263148 | 2041-12-21 | U-219 | 2025-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12263148 | 2041-12-21 | U-4005 | 2025-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12263149 | 2041-12-21 | U-1649 | 2025-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12263149 | 2041-12-21 | U-219 | 2025-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12263149 | 2041-12-21 | U-4004 | 2025-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12263149 | 2041-12-21 | U-4005 | 2025-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12295931 | 2041-12-21 | U-1649 | 2025-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12295931 | 2041-12-21 | U-4005 | 2025-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12295931 | 2041-12-21 | U-4004 | 2025-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12295931 | 2041-12-21 | U-219 | 2025-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12303481 | 2041-12-21 | U-1649 | 2025-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12303481 | 2041-12-21 | U-219 | 2025-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | 12303481 | 2041-12-21 | U-4004 | 2025-06-20 | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N217186-001 | NP | 2027-08-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-002 | NP | 2027-08-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-003 | NP | 2027-08-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N217186-004 | NP | 2027-08-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217186-001 | NP | 2027-08-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217186-002 | NP | 2027-08-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217186-003 | NP | 2027-08-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217186-004 | NP | 2027-08-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N217186-001 | NP | 2027-08-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N217186-002 | NP | 2027-08-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N217186-003 | NP | 2027-08-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N217186-004 | NP | 2027-08-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217186-001 | NP | 2027-08-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217186-002 | NP | 2027-08-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217186-003 | NP | 2027-08-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217186-004 | NP | 2027-08-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217186-001 | NP | 2027-08-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217186-002 | NP | 2027-08-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217186-003 | NP | 2027-08-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217186-004 | NP | 2027-08-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217186-001 | NP | 2027-08-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217186-002 | NP | 2027-08-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217186-003 | NP | 2027-08-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217186-004 | NP | 2027-08-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217186-001 | NP | 2027-08-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217186-002 | NP | 2027-08-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217186-003 | NP | 2027-08-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217186-004 | NP | 2027-08-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217186-001 | NP | 2027-08-07 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217186-002 | NP | 2027-08-07 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217186-003 | NP | 2027-08-07 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217186-004 | NP | 2027-08-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217186-001 | NP | 2027-08-07 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217186-002 | NP | 2027-08-07 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217186-003 | NP | 2027-08-07 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217186-004 | NP | 2027-08-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N217186-001 | NP | 2027-08-07 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N217186-002 | NP | 2027-08-07 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N217186-003 | NP | 2027-08-07 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N217186-004 | NP | 2027-08-07 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| CREXONT | CARBIDOPA AND LEVODOPA | Amneal Pharmaceuticals LLC | 095a08b6-b0b8-4f88-b759-67e8b87287a0 | 2026-05-29 | Warnings, Adverse reactions | 217186 NDA217186 |