Application 209500
- Type
- NDA
- Sponsor
- INTRA-CELLULAR
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CAPLYTA | LUMATEPERONE TOSYLATE | CAPSULE;ORAL | EQ 42MG BASE | Yes | Yes |
| 002 | CAPLYTA | LUMATEPERONE TOSYLATE | CAPSULE;ORAL | EQ 10.5MG BASE | Yes | No |
| 003 | CAPLYTA | LUMATEPERONE TOSYLATE | CAPSULE;ORAL | EQ 21MG BASE | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70518-3497 | CAPLYTA | lumateperone | REMEDYREPACK INC. | NDA | Current |
| 72060-110 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-110 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-121 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-121 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-142 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-142 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-142 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-142 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-142 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-142 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-142 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
| 72060-142 | CAPLYTA | lumateperone | Intra-Cellular Therapies, Inc | NDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|---|---|---|---|---|
| 85775 | 0 | SUPPL | 17 | 2026-04-28 | Cached in FDA.report object storage |
| 85771 | 0 | SUPPL | 17 | 2026-04-27 | Cached in FDA.report object storage |
| 84120 | 0 | SUPPL | 16 | 2025-11-06 | Cached in FDA.report object storage |
| 84119 | 0 | SUPPL | 16 | 2025-11-06 | Cached in FDA.report object storage |
| 84091 | 0 | SUPPL | 16 | 2025-11-06 | Cached in FDA.report object storage |
| 74660 | 0 | SUPPL | 11 | 2023-06-29 | Cached in FDA.report object storage |
| 74654 | 0 | SUPPL | 11 | 2023-06-29 | Cached in FDA.report object storage |
| 70835 | 0 | SUPPL | 9 | 2022-04-27 | Cached in FDA.report object storage |
| 70834 | 0 | SUPPL | 9 | 2022-04-27 | Cached in FDA.report object storage |
| 70725 | 0 | SUPPL | 6 | 2022-04-07 | Cached in FDA.report object storage |
| 70724 | 0 | SUPPL | 5 | 2022-04-07 | Cached in FDA.report object storage |
| 69719 | 0 | SUPPL | 6 | 2021-12-21 | Cached in FDA.report object storage |
| 69718 | 0 | SUPPL | 5 | 2021-12-21 | Cached in FDA.report object storage |
| 69644 | 0 | SUPPL | 6 | 2021-12-19 | Cached in FDA.report object storage |
| 69643 | 0 | SUPPL | 6 | 2021-12-19 | Cached in FDA.report object storage |
| 69642 | 0 | SUPPL | 5 | 2021-12-19 | Cached in FDA.report object storage |
| 61607 | 0 | ORIG | 1 | 2020-01-21 | FDA source fallback |
| 61606 | 0 | ORIG | 1 | 2020-01-21 | FDA source fallback |
| 61400 | 0 | SUPPL | 1 | 2019-12-23 | FDA source fallback |
| 61374 | 0 | SUPPL | 1 | 2019-12-23 | FDA source fallback |