| 65757-652-42 |
65757-652 |
HUMAN PRESCRIPTION DRUG |
LYBALVI |
olanzapine and samidorphan L-malate |
TABLET, FILM COATED |
ORAL |
20210920 |
N/A |
NDA |
NDA213378 |
Alkermes, Inc. |
OLANZAPINE; SAMIDORPHAN L-MALATE |
10 mg/1; 10 mg/1 |
1 BOTTLE in 1 CARTON (65757-652-42) / 30 TABLET, FILM COATED in 1 BOTTLE |
| 65757-653-41 |
65757-653 |
HUMAN PRESCRIPTION DRUG |
LYBALVI |
olanzapine and samidorphan L-malate |
TABLET, FILM COATED |
ORAL |
20210920 |
N/A |
NDA |
NDA213378 |
Alkermes, Inc. |
OLANZAPINE; SAMIDORPHAN L-MALATE |
15 mg/1; 10 mg/1 |
1 BOTTLE in 1 CARTON (65757-653-41) / 7 TABLET, FILM COATED in 1 BOTTLE |
| 65757-653-42 |
65757-653 |
HUMAN PRESCRIPTION DRUG |
LYBALVI |
olanzapine and samidorphan L-malate |
TABLET, FILM COATED |
ORAL |
20210920 |
N/A |
NDA |
NDA213378 |
Alkermes, Inc. |
OLANZAPINE; SAMIDORPHAN L-MALATE |
15 mg/1; 10 mg/1 |
1 BOTTLE in 1 CARTON (65757-653-42) / 30 TABLET, FILM COATED in 1 BOTTLE |
| 65757-654-41 |
65757-654 |
HUMAN PRESCRIPTION DRUG |
LYBALVI |
olanzapine and samidorphan L-malate |
TABLET, FILM COATED |
ORAL |
20210920 |
N/A |
NDA |
NDA213378 |
Alkermes, Inc. |
OLANZAPINE; SAMIDORPHAN L-MALATE |
20 mg/1; 10 mg/1 |
1 BOTTLE in 1 CARTON (65757-654-41) / 7 TABLET, FILM COATED in 1 BOTTLE |
| 65757-654-42 |
65757-654 |
HUMAN PRESCRIPTION DRUG |
LYBALVI |
olanzapine and samidorphan L-malate |
TABLET, FILM COATED |
ORAL |
20210920 |
N/A |
NDA |
NDA213378 |
Alkermes, Inc. |
OLANZAPINE; SAMIDORPHAN L-MALATE |
20 mg/1; 10 mg/1 |
1 BOTTLE in 1 CARTON (65757-654-42) / 30 TABLET, FILM COATED in 1 BOTTLE |
| 65757-652-41 |
65757-652 |
HUMAN PRESCRIPTION DRUG |
LYBALVI |
olanzapine and samidorphan L-malate |
TABLET, FILM COATED |
ORAL |
20210920 |
N/A |
NDA |
NDA213378 |
Alkermes, Inc. |
OLANZAPINE; SAMIDORPHAN L-MALATE |
10 mg/1; 10 mg/1 |
1 BOTTLE in 1 CARTON (65757-652-41) / 7 TABLET, FILM COATED in 1 BOTTLE |
| 65757-651-42 |
65757-651 |
HUMAN PRESCRIPTION DRUG |
LYBALVI |
olanzapine and samidorphan L-malate |
TABLET, FILM COATED |
ORAL |
20210920 |
N/A |
NDA |
NDA213378 |
Alkermes, Inc. |
OLANZAPINE; SAMIDORPHAN L-MALATE |
5 mg/1; 10 mg/1 |
1 BOTTLE in 1 CARTON (65757-651-42) / 30 TABLET, FILM COATED in 1 BOTTLE |
| 65757-651-41 |
65757-651 |
HUMAN PRESCRIPTION DRUG |
LYBALVI |
olanzapine and samidorphan L-malate |
TABLET, FILM COATED |
ORAL |
20210920 |
N/A |
NDA |
NDA213378 |
Alkermes, Inc. |
OLANZAPINE; SAMIDORPHAN L-MALATE |
5 mg/1; 10 mg/1 |
1 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE |