Application 207533
- Type
- NDA
- Sponsor
- ALKERMES INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARISTADA | ARIPIPRAZOLE LAUROXIL | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 441MG/1.6ML (275.63MG/ML) | Yes | No |
| 002 | ARISTADA | ARIPIPRAZOLE LAUROXIL | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 662MG/2.4ML (275.83MG/ML) | Yes | No |
| 003 | ARISTADA | ARIPIPRAZOLE LAUROXIL | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 882MG/3.2ML (275.63MG/ML) | Yes | Yes |
| 004 | ARISTADA | ARIPIPRAZOLE LAUROXIL | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 1064MG/3.9ML (272.82MG/ML) | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65757-401 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-401 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-401 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-401 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-401 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-401 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-401 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-401 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-402 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-402 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-402 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-402 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-402 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-402 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-402 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-402 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-403 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-403 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-403 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-403 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-403 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-403 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-403 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-403 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-404 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-404 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-404 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-404 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-404 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-404 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-404 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
| 65757-404 | ARISTADA | aripiprazole lauroxil | Alkermes, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81150 | SUPPL | 2025-02-07 |
| 80952 | SUPPL | 2025-02-05 |
| 80951 | SUPPL | 2025-02-05 |
| 66932 | SUPPL | 2021-03-31 |
| 64504 | SUPPL | 2020-09-04 |
| 64503 | SUPPL | 2020-09-04 |
| 64442 | SUPPL | 2020-08-28 |
| 56616 | SUPPL | 2018-12-03 |
| 52123 | SUPPL | 2018-01-30 |
| 48666 | SUPPL | 2017-06-07 |
| 48660 | SUPPL | 2017-06-06 |
| 48659 | SUPPL | 2017-06-06 |
| 47406 | SUPPL | 2017-03-02 |
| 47322 | SUPPL | 2017-02-24 |
| 45097 | SUPPL | 2016-08-22 |
| 45143 | SUPPL | 2016-08-18 |
| 23036 | ORIG | 2015-10-28 |
| 24526 | ORIG | 2015-10-16 |
| 19963 | ORIG | 2015-10-13 |
| 10619 | ORIG | 2015-10-13 |