| 68382-112-10 |
68382-112 |
HUMAN PRESCRIPTION DRUG |
risperidone |
risperidone |
TABLET, FILM COATED |
ORAL |
20081113 |
N/A |
ANDA |
ANDA078040 |
Zydus Pharmaceuticals USA Inc. |
RISPERIDONE |
.25 mg/1 |
1000 TABLET, FILM COATED in 1 BOTTLE (68382-112-10) |
| 0904-7360-61 |
0904-7360 |
HUMAN PRESCRIPTION DRUG |
risperidone |
risperidone |
TABLET, FILM COATED |
ORAL |
20231027 |
N/A |
ANDA |
ANDA078040 |
Major Pharmaceuticals |
RISPERIDONE |
.25 mg/1 |
100 BLISTER PACK in 1 CARTON (0904-7360-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 0904-7361-61 |
0904-7361 |
HUMAN PRESCRIPTION DRUG |
risperidone |
risperidone |
TABLET, FILM COATED |
ORAL |
20231027 |
N/A |
ANDA |
ANDA078040 |
Major Pharmaceuticals |
RISPERIDONE |
.5 mg/1 |
100 BLISTER PACK in 1 CARTON (0904-7361-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 0904-7362-61 |
0904-7362 |
HUMAN PRESCRIPTION DRUG |
risperidone |
risperidone |
TABLET, FILM COATED |
ORAL |
20231027 |
N/A |
ANDA |
ANDA078040 |
Major Pharmaceuticals |
RISPERIDONE |
1 mg/1 |
100 BLISTER PACK in 1 CARTON (0904-7362-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 0904-7363-61 |
0904-7363 |
HUMAN PRESCRIPTION DRUG |
risperidone |
risperidone |
TABLET, FILM COATED |
ORAL |
20231027 |
N/A |
ANDA |
ANDA078040 |
Major Pharmaceuticals |
RISPERIDONE |
2 mg/1 |
100 BLISTER PACK in 1 CARTON (0904-7363-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 0904-7364-61 |
0904-7364 |
HUMAN PRESCRIPTION DRUG |
risperidone |
risperidone |
TABLET, FILM COATED |
ORAL |
20231027 |
N/A |
ANDA |
ANDA078040 |
Major Pharmaceuticals |
RISPERIDONE |
3 mg/1 |
100 BLISTER PACK in 1 CARTON (0904-7364-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 0904-7365-61 |
0904-7365 |
HUMAN PRESCRIPTION DRUG |
risperidone |
risperidone |
TABLET, FILM COATED |
ORAL |
20231027 |
N/A |
ANDA |
ANDA078040 |
Major Pharmaceuticals |
RISPERIDONE |
4 mg/1 |
100 BLISTER PACK in 1 CARTON (0904-7365-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |