Application 216352
- Type
- NDA
- Sponsor
- LUYE INNOMIND PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 39MG/0.25ML (39MG/0.25ML) | Yes | Yes |
| 002 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 78MG/0.5ML (78MG/0.5ML) | Yes | Yes |
| 003 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 117MG/0.75ML (117MG/0.75ML) | Yes | Yes |
| 004 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 156MG/ML (156MG/ML) | Yes | Yes |
| 005 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 234MG/1.5ML (156MG/ML) | Yes | Yes |
| 006 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 351MG/2.25ML (156MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216352-001 | ERZOFRI | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | |
| N216352-002 | ERZOFRI | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | |
| N216352-003 | ERZOFRI | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | |
| N216352-004 | ERZOFRI | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | |
| N216352-005 | ERZOFRI | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | |
| N216352-006 | ERZOFRI | PALIPERIDONE PALMITATE | 351MG/2.25ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216352-001 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | |
| N216352-001 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | |
| N216352-001 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | |
| N216352-001 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | |
| N216352-002 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | |
| N216352-002 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | |
| N216352-002 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | |
| N216352-002 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | |
| N216352-003 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | |
| N216352-003 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | |
| N216352-003 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | |
| N216352-003 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | |
| N216352-004 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | |
| N216352-004 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | |
| N216352-004 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | |
| N216352-004 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | |
| N216352-005 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | |
| N216352-005 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | |
| N216352-005 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | |
| N216352-005 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | |
| N216352-006 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | |
| N216352-006 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | |
| N216352-006 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | |
| N216352-006 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 |
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 | N216352-001 | ERZOFRI | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-002 | ERZOFRI | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-003 | ERZOFRI | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-004 | ERZOFRI | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-005 | ERZOFRI | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-006 | ERZOFRI | 351MG/2.25ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-001 | ERZOFRI | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-002 | ERZOFRI | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-003 | ERZOFRI | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-004 | ERZOFRI | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-005 | ERZOFRI | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-006 | ERZOFRI | 351MG/2.25ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216352-001 | ERZOFRI | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216352-002 | ERZOFRI | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216352-003 | ERZOFRI | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216352-004 | ERZOFRI | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216352-005 | ERZOFRI | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216352-006 | ERZOFRI | 351MG/2.25ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216352-001 | ERZOFRI | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216352-002 | ERZOFRI | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216352-003 | ERZOFRI | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216352-004 | ERZOFRI | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216352-005 | ERZOFRI | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216352-006 | ERZOFRI | 351MG/2.25ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216352-001 | ERZOFRI | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216352-002 | ERZOFRI | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216352-003 | ERZOFRI | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216352-004 | ERZOFRI | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216352-005 | ERZOFRI | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216352-006 | ERZOFRI | 351MG/2.25ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216352-001 | ERZOFRI | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216352-002 | ERZOFRI | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216352-003 | ERZOFRI | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216352-004 | ERZOFRI | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216352-005 | ERZOFRI | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216352-006 | ERZOFRI | 351MG/2.25ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216352-001 | ERZOFRI | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216352-002 | ERZOFRI | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216352-003 | ERZOFRI | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216352-004 | ERZOFRI | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2024-07-26 | 2680178bc6a6… |
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 | N216352-001 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-001 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-001 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-001 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-002 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-002 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-002 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-002 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-003 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-003 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-003 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-003 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-004 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-004 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-004 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-004 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-005 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-005 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-005 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-005 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-006 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-006 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-006 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216352-006 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-001 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-001 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-001 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-001 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-002 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-002 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-002 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-002 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-003 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-003 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-003 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-003 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-004 | 12128049 | 2038-10-26 | U-3969 | 2024-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-004 | 12128049 | 2038-10-26 | U-3968 | 2024-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-004 | 11666573 | 2039-09-24 | U-3969 | 2024-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216352-004 | 11666573 | 2039-09-24 | U-3968 | 2024-07-30 | 31067a03dcf5… |
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 |
|---|---|---|---|---|---|---|
| Erzofri extended-release | PALIPERIDONE PALMITATE | Shandong Luye Pharmaceutical Co., Ltd. | 492bf9dd-868e-421a-92db-8cca8973aac1 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 216352 NDA216352 |