| 15370-401-30 |
15370-401 |
HUMAN PRESCRIPTION DRUG |
OPIPZA |
ARIPIPRAZOLE |
FILM, SOLUBLE |
ORAL |
20241101 |
N/A |
NDA |
NDA216655 |
Carwin Pharmaceutical Associates, LLC |
ARIPIPRAZOLE |
2 mg/1 |
30 POUCH in 1 CARTON (15370-401-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-401-01) |
| 15370-401-99 |
15370-401 |
HUMAN PRESCRIPTION DRUG |
OPIPZA |
ARIPIPRAZOLE |
FILM, SOLUBLE |
ORAL |
20250128 |
N/A |
NDA |
NDA216655 |
Carwin Pharmaceutical Associates, LLC |
ARIPIPRAZOLE |
2 mg/1 |
2 POUCH in 1 CARTON (15370-401-99) / 1 FILM, SOLUBLE in 1 POUCH |
| 15370-403-30 |
15370-403 |
HUMAN PRESCRIPTION DRUG |
OPIPZA |
ARIPIPRAZOLE |
FILM, SOLUBLE |
ORAL |
20241101 |
N/A |
NDA |
NDA216655 |
Carwin Pharmaceutical Associates, LLC |
ARIPIPRAZOLE |
10 mg/1 |
30 POUCH in 1 CARTON (15370-403-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-403-01) |
| 15370-402-30 |
15370-402 |
HUMAN PRESCRIPTION DRUG |
OPIPZA |
ARIPIPRAZOLE |
FILM, SOLUBLE |
ORAL |
20241101 |
N/A |
NDA |
NDA216655 |
Carwin Pharmaceutical Associates, LLC |
ARIPIPRAZOLE |
5 mg/1 |
30 POUCH in 1 CARTON (15370-402-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-402-01) |
| 15370-402-99 |
15370-402 |
HUMAN PRESCRIPTION DRUG |
OPIPZA |
ARIPIPRAZOLE |
FILM, SOLUBLE |
ORAL |
20250128 |
N/A |
NDA |
NDA216655 |
Carwin Pharmaceutical Associates, LLC |
ARIPIPRAZOLE |
5 mg/1 |
2 POUCH in 1 CARTON (15370-402-99) / 1 FILM, SOLUBLE in 1 POUCH (15370-402-01) |