Application 203255
- Type
- NDA
- Sponsor
- RECORDATI RARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | FOR SUSPENSION;INTRAMUSCULAR | EQ 20MG BASE/VIAL | Yes | No |
| 002 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | FOR SUSPENSION;INTRAMUSCULAR | EQ 40MG BASE/VIAL | Yes | No |
| 003 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | FOR SUSPENSION;INTRAMUSCULAR | EQ 60MG BASE/VIAL | Yes | Yes |
| 004 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | FOR SUSPENSION;INTRAMUSCULAR | EQ 10MG BASE/VIAL | Yes | No |
| 005 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | FOR SUSPENSION;INTRAMUSCULAR | EQ 30MG BASE/VIAL | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N203255-001 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 20MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | |
| N203255-002 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 40MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | |
| N203255-003 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 60MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD, RS | 2014-12-15 | |
| N203255-004 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 10MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | |
| N203255-005 | SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | EQ 30MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N203255-001 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | |
| N203255-001 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | |
| N203255-001 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | |
| N203255-002 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | |
| N203255-002 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | |
| N203255-002 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | |
| N203255-003 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | |
| N203255-003 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | |
| N203255-003 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | |
| N203255-004 | 7759308 | 2026-10-25 | Drug product | 2019-09-11 | |
| N203255-004 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2019-09-11 | |
| N203255-004 | 9351923 | 2028-05-23 | Drug product | 2019-09-11 | |
| N203255-005 | 7759308 | 2026-10-25 | Drug product | 2019-09-11 | |
| N203255-005 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2019-09-11 | |
| N203255-005 | 9351923 | 2028-05-23 | Drug product | 2019-09-11 |
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 | N203255-001 | SIGNIFOR LAR KIT | EQ 20MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-002 | SIGNIFOR LAR KIT | EQ 40MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-003 | SIGNIFOR LAR KIT | EQ 60MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD, RS | 2014-12-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-004 | SIGNIFOR LAR KIT | EQ 10MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-005 | SIGNIFOR LAR KIT | EQ 30MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-001 | SIGNIFOR LAR KIT | EQ 20MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-002 | SIGNIFOR LAR KIT | EQ 40MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-003 | SIGNIFOR LAR KIT | EQ 60MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD, RS | 2014-12-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-004 | SIGNIFOR LAR KIT | EQ 10MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-005 | SIGNIFOR LAR KIT | EQ 30MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-001 | SIGNIFOR LAR KIT | EQ 20MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-002 | SIGNIFOR LAR KIT | EQ 40MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-003 | SIGNIFOR LAR KIT | EQ 60MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD, RS | 2014-12-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-004 | SIGNIFOR LAR KIT | EQ 10MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-005 | SIGNIFOR LAR KIT | EQ 30MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-001 | SIGNIFOR LAR KIT | EQ 20MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-002 | SIGNIFOR LAR KIT | EQ 40MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-003 | SIGNIFOR LAR KIT | EQ 60MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD, RS | 2014-12-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-004 | SIGNIFOR LAR KIT | EQ 10MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-005 | SIGNIFOR LAR KIT | EQ 30MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-001 | SIGNIFOR LAR KIT | EQ 20MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-002 | SIGNIFOR LAR KIT | EQ 40MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-003 | SIGNIFOR LAR KIT | EQ 60MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD, RS | 2014-12-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-004 | SIGNIFOR LAR KIT | EQ 10MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-005 | SIGNIFOR LAR KIT | EQ 30MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-001 | SIGNIFOR LAR KIT | EQ 20MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-002 | SIGNIFOR LAR KIT | EQ 40MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-003 | SIGNIFOR LAR KIT | EQ 60MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD, RS | 2014-12-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-004 | SIGNIFOR LAR KIT | EQ 10MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-005 | SIGNIFOR LAR KIT | EQ 30MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-001 | SIGNIFOR LAR KIT | EQ 20MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-002 | SIGNIFOR LAR KIT | EQ 40MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-003 | SIGNIFOR LAR KIT | EQ 60MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD, RS | 2014-12-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-004 | SIGNIFOR LAR KIT | EQ 10MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-005 | SIGNIFOR LAR KIT | EQ 30MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-001 | SIGNIFOR LAR KIT | EQ 20MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-002 | SIGNIFOR LAR KIT | EQ 40MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2014-12-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-003 | SIGNIFOR LAR KIT | EQ 60MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD, RS | 2014-12-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-004 | SIGNIFOR LAR KIT | EQ 10MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-005 | SIGNIFOR LAR KIT | EQ 30MG BASE/VIAL | FOR SUSPENSION / INTRAMUSCULAR | RLD | 2018-06-29 | 5bbf6a4d5a75… |
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 | N203255-001 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-001 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-001 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-002 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-002 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-002 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-003 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-003 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-003 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-004 | 7759308 | 2026-10-25 | Drug product | 2019-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-004 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2019-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-004 | 9351923 | 2028-05-23 | Drug product | 2019-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-005 | 7759308 | 2026-10-25 | Drug product | 2019-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-005 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2019-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203255-005 | 9351923 | 2028-05-23 | Drug product | 2019-09-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-001 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-001 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-001 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-002 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-002 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-002 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-003 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-003 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-003 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-004 | 7759308 | 2026-10-25 | Drug product | 2019-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-004 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2019-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-004 | 9351923 | 2028-05-23 | Drug product | 2019-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-005 | 7759308 | 2026-10-25 | Drug product | 2019-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-005 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2019-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-005 | 9351923 | 2028-05-23 | Drug product | 2019-09-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-001 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-001 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-001 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-002 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-002 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-002 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-003 | 7759308 | 2026-10-25 | Drug product | 2015-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-003 | 7473761 | 2026-12-14 | Drug substance, Drug product | 2015-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-003 | 9351923 | 2028-05-23 | Drug product | 2017-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-004 | 7759308 | 2026-10-25 | Drug product | 2019-09-11 | 6a471c1ec25d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-001 | ODE-268 | 2025-06-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-002 | ODE-268 | 2025-06-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-003 | ODE-268 | 2025-06-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-004 | ODE-268 | 2025-06-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203255-005 | ODE-268 | 2025-06-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-001 | ODE-268 | 2025-06-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-002 | ODE-268 | 2025-06-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-003 | ODE-268 | 2025-06-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-004 | ODE-268 | 2025-06-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203255-005 | ODE-268 | 2025-06-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-001 | ODE-268 | 2025-06-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-002 | ODE-268 | 2025-06-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-003 | ODE-268 | 2025-06-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-004 | ODE-268 | 2025-06-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203255-005 | ODE-268 | 2025-06-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-001 | ODE-268 | 2025-06-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-002 | ODE-268 | 2025-06-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-003 | ODE-268 | 2025-06-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-004 | ODE-268 | 2025-06-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203255-005 | ODE-268 | 2025-06-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-001 | ODE-268 | 2025-06-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-002 | ODE-268 | 2025-06-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-003 | ODE-268 | 2025-06-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-004 | ODE-268 | 2025-06-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203255-005 | ODE-268 | 2025-06-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-001 | ODE-268 | 2025-06-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-002 | ODE-268 | 2025-06-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-003 | ODE-268 | 2025-06-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-004 | ODE-268 | 2025-06-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203255-005 | ODE-268 | 2025-06-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-001 | ODE-268 | 2025-06-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-002 | ODE-268 | 2025-06-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-003 | ODE-268 | 2025-06-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-004 | ODE-268 | 2025-06-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N203255-005 | ODE-268 | 2025-06-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203255-001 | ODE-268 | 2025-06-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203255-002 | ODE-268 | 2025-06-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203255-003 | ODE-268 | 2025-06-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203255-004 | ODE-268 | 2025-06-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N203255-005 | ODE-268 | 2025-06-29 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Signifor LAR | PASIREOTIDE | Recordati Rare Diseases, Inc. | a0aad470-3f38-af97-e053-2995a90a383a | 2024-07-16 | Warnings, Adverse reactions | 203255 NDA203255 55292-141 55292-140 55292-139 55292-142 55292-143 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0641 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0641 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0641 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0641 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0641 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0641 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0642 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0642 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0642 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0642 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0642 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0642 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0643 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0643 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0643 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0643 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0643 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0643 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0741 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0741 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0741 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0741 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0741 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0748 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0748 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0748 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0748 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0748 | Signifor LAR | pasireotide | Novartis Pharmaceuticals Corporation | NDA | Current |
| 55292-139 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-139 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-139 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-140 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-140 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-140 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-141 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-141 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-141 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-142 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-142 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-142 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-143 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-143 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
| 55292-143 | Signifor LAR | pasireotide | Recordati Rare Diseases Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79090 | SUPPL | 2024-07-15 |
| 79067 | SUPPL | 2024-07-15 |
| 63843 | SUPPL | 2020-07-10 |
| 63840 | SUPPL | 2020-07-10 |
| 58335 | SUPPL | 2019-04-15 |
| 58310 | SUPPL | 2019-04-12 |
| 57579 | SUPPL | 2019-02-13 |
| 57384 | SUPPL | 2019-01-30 |
| 54822 | SUPPL | 2018-07-06 |
| 54803 | SUPPL | 2018-07-06 |
| 54764 | SUPPL | 2018-07-05 |
| 52991 | SUPPL | 2018-03-15 |
| 52933 | SUPPL | 2018-03-13 |
| 24430 | ORIG | 2016-03-02 |
| 22918 | ORIG | 2016-03-02 |
| 40282 | ORIG | 2014-12-16 |
| 10193 | ORIG | 2014-12-16 |