Application 216608
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARIPIPRAZOLE | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 300MG/VIAL | No | No |
| 002 | ARIPIPRAZOLE | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 400MG/VIAL | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81193 | ORIG | 2025-02-10 |