FdaApplication
NDA 207533
Identifiers
- fda_app_no: NDA207533
Properties
| Property | Value |
|---|---|
| applicant_name | ALKERMES INC |
| application_type | NDA |
| approval_date | 2015-10-05 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ARISTADA | ARIPIPRAZOLE LAUROXIL | 441MG/1.6ML (275.63MG/ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | 662MG/2.4ML (275.83MG/ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | 882MG/3.2ML (275.63MG/ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | 1064MG/3.9ML (272.82MG/ML) | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
4 products