Application 213871
- Type
- NDA
- Sponsor
- PFIZER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIBINQO | ABROCITINIB | TABLET;ORAL | 50MG | Yes | No |
| 002 | CIBINQO | ABROCITINIB | TABLET;ORAL | 100MG | Yes | No |
| 003 | CIBINQO | ABROCITINIB | TABLET; ORAL | 200MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N213871-001 | CIBINQO | ABROCITINIB | 50MG | TABLET / ORAL | RLD | 2022-01-14 | |
| N213871-002 | CIBINQO | ABROCITINIB | 100MG | TABLET / ORAL | RLD | 2022-01-14 | |
| N213871-003 | CIBINQO | ABROCITINIB | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N213871-001 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | |
| N213871-001 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | |
| N213871-001 | 9035074 | 2036-01-14 | Drug substance, Drug product | 2022-02-11 | |
| N213871-002 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | |
| N213871-002 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | |
| N213871-002 | 9035074 | 2036-01-14 | Drug substance, Drug product | 2022-02-11 | |
| N213871-003 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | |
| N213871-003 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | |
| N213871-003 | 9035074 | 2036-01-14 | Drug substance, Drug product | 2022-02-11 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N213871-001 | NPP | 2026-02-09 |
| N213871-001 | NCE | 2027-01-14 |
| N213871-002 | NPP | 2026-02-09 |
| N213871-002 | NCE | 2027-01-14 |
| N213871-003 | NPP | 2026-02-09 |
| N213871-003 | NCE | 2027-01-14 |
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 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N213871-002 | CIBINQO | 100MG | TABLET / ORAL | RLD | 2022-01-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N213871-003 | CIBINQO | 200MG | TABLET / ORAL | RLD, RS | 2022-01-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N213871-001 | CIBINQO | 50MG | TABLET / ORAL | RLD | 2022-01-14 | 8072bd15b7f6… |
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 | N213871-001 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-001 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-001 | 9035074 | 2036-01-14 | Drug substance, Drug product | 2022-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-002 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-002 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-002 | 9035074 | 2036-01-14 | Drug substance, Drug product | 2022-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-003 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-003 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-003 | 9035074 | 2036-01-14 | Drug substance, Drug product | 2022-02-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-001 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-001 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-001 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-002 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-002 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-002 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-003 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-003 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-003 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-001 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-001 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-001 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-002 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-002 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-002 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-003 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-003 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-003 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-001 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-001 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-001 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-002 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-002 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-002 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-003 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-003 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-003 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-001 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-001 | 9545405 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-001 | 9549929 | 2034-02-19 | U-3195 | 2022-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-002 | 9035074 | 2034-02-19 | Drug substance, Drug product | 2022-02-11 | b8a1b40f171c… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N213871-001 | NPP | 2026-02-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-001 | NCE | 2027-01-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-002 | NPP | 2026-02-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-002 | NCE | 2027-01-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-003 | NPP | 2026-02-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213871-003 | NCE | 2027-01-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-001 | NPP | 2026-02-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-001 | NCE | 2027-01-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-002 | NPP | 2026-02-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-002 | NCE | 2027-01-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-003 | NPP | 2026-02-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213871-003 | NCE | 2027-01-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-001 | NPP | 2026-02-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-001 | NCE | 2027-01-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-002 | NPP | 2026-02-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-002 | NCE | 2027-01-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-003 | NPP | 2026-02-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213871-003 | NCE | 2027-01-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-001 | NPP | 2026-02-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-001 | NCE | 2027-01-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-002 | NPP | 2026-02-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-002 | NCE | 2027-01-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-003 | NPP | 2026-02-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213871-003 | NCE | 2027-01-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-001 | NPP | 2026-02-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-001 | NCE | 2027-01-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-002 | NPP | 2026-02-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-002 | NCE | 2027-01-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-003 | NPP | 2026-02-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213871-003 | NCE | 2027-01-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213871-001 | NPP | 2026-02-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213871-001 | NCE | 2027-01-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213871-002 | NPP | 2026-02-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213871-002 | NCE | 2027-01-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213871-003 | NPP | 2026-02-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213871-003 | NCE | 2027-01-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213871-001 | NPP | 2026-02-09 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213871-001 | NCE | 2027-01-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213871-002 | NPP | 2026-02-09 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213871-002 | NCE | 2027-01-14 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| CIBINQO | ABROCITINIB | U.S. Pharmaceuticals | 16c12a56-4550-414b-ac9d-b785b41fea6b | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 213871 NDA213871 63539-236 63539-436 63539-336 |
| Cibinqo | ABROCITINIB | Pfizer Laboratories Div Pfizer Inc | 3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 213871 NDA213871 0069-0335 0069-0435 0069-0235 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-0235 | Cibinqo | abrocitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0335 | Cibinqo | abrocitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0435 | Cibinqo | abrocitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 63539-236 | CIBINQO | abrocitinib | U.S. Pharmaceuticals | NDA | Current |
| 63539-336 | CIBINQO | abrocitinib | U.S. Pharmaceuticals | NDA | Current |
| 63539-436 | CIBINQO | abrocitinib | U.S. Pharmaceuticals | NDA | Current |