| 213378 | NDA | ALKERMES INC | | 001 | LYBALVI | TABLET;ORAL | 5MG;EQ 10MG BASE | OLANZAPINE; SAMIDORPHAN L-MALATE | 2021-05-28 | Prescription | Yes |
| 002 | LYBALVI | TABLET;ORAL | 10MG;EQ 10MG BASE | OLANZAPINE; SAMIDORPHAN L-MALATE | 2021-05-28 | Prescription | No |
| 003 | LYBALVI | TABLET;ORAL | 15MG;EQ 10MG BASE | OLANZAPINE; SAMIDORPHAN L-MALATE | 2021-05-28 | Prescription | No |
| 004 | LYBALVI | TABLET;ORAL | 20MG;EQ 10MG BASE | OLANZAPINE; SAMIDORPHAN L-MALATE | 2021-05-28 | Prescription | No |
| 209830 | NDA | ALKERMES INC | | 001 | ARISTADA INITIO KIT | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 675MG/2.4ML (281.25MG/ML) | ARIPIPRAZOLE LAUROXIL | 2018-06-29 | Prescription | Yes |
| 207533 | NDA | ALKERMES INC | | 001 | ARISTADA | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 441MG/1.6ML (275.63MG/ML) | ARIPIPRAZOLE LAUROXIL | 2015-10-05 | Prescription | No |
| 002 | ARISTADA | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 662MG/2.4ML (275.83MG/ML) | ARIPIPRAZOLE LAUROXIL | 2015-10-05 | Prescription | No |
| 003 | ARISTADA | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 882MG/3.2ML (275.63MG/ML) | ARIPIPRAZOLE LAUROXIL | 2015-10-05 | Prescription | Yes |
| 004 | ARISTADA | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 1064MG/3.9ML (272.82MG/ML) | ARIPIPRAZOLE LAUROXIL | 2015-10-05 | Prescription | No |
| 021897 | NDA | ALKERMES | | 001 | VIVITROL | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 380MG/VIAL | NALTREXONE | 2006-04-13 | Prescription | Yes |