Application 204370
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 1.5MG BASE | Yes | No |
| 002 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 3MG BASE | Yes | No |
| 003 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4.5MG BASE | Yes | No |
| 004 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | Yes | Yes |
| 005 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | Yes | No |
| 006 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.75MG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61874-115 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-115 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-115 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-115 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-115 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-115 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-130 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-130 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-130 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-130 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-130 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-130 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-145 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-145 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-145 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-145 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-145 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-145 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-160 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-160 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-160 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-160 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-160 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-160 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-170 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-170 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-170 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-170 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-170 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 61874-170 | Vraylar | cariprazine | Allergan, Inc. | NDA | Current |
| 70518-3157 | Vraylar | cariprazine | REMEDYREPACK INC. | NDA | Current |
| 70518-3157 | Vraylar | cariprazine | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85143 | SUPPL | 2026-02-24 |
| 85141 | SUPPL | 2026-02-24 |
| 84490 | SUPPL | 2025-12-22 |
| 84489 | SUPPL | 2025-12-22 |
| 84488 | SUPPL | 2025-12-22 |
| 84487 | SUPPL | 2025-12-22 |
| 84479 | SUPPL | 2025-12-19 |
| 84478 | SUPPL | 2025-12-19 |
| 84477 | SUPPL | 2025-12-19 |
| 84476 | SUPPL | 2025-12-19 |
| 80422 | SUPPL | 2024-11-26 |
| 80344 | SUPPL | 2024-11-25 |
| 80342 | SUPPL | 2024-11-25 |
| 72928 | SUPPL | 2022-12-20 |
| 72924 | SUPPL | 2022-12-19 |
| 72923 | SUPPL | 2022-12-19 |
| 58946 | SUPPL | 2019-06-04 |
| 58878 | SUPPL | 2019-05-29 |
| 58877 | SUPPL | 2019-05-24 |
| 56809 | SUPPL | 2018-12-19 |
| 50431 | SUPPL | 2017-11-15 |
| 50430 | SUPPL | 2017-11-15 |
| 50405 | SUPPL | 2017-11-14 |
| 50404 | SUPPL | 2017-11-14 |
| 47397 | SUPPL | 2017-03-02 |
| 47308 | SUPPL | 2017-02-24 |
| 22954 | ORIG | 2015-10-28 |
| 40380 | ORIG | 2015-09-18 |
| 10333 | ORIG | 2015-09-18 |