| 71699-025-30 |
71699-025 |
HUMAN PRESCRIPTION DRUG |
Xcopri |
cenobamate |
TABLET, FILM COATED |
ORAL |
20240406 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
CENOBAMATE |
25 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (71699-025-30) |
| 71699-104-56 |
71699-104 |
HUMAN PRESCRIPTION DRUG |
Xcopri Maintenance Pack |
cenobamate |
KIT |
ORAL |
20210430 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
|
|
1 KIT in 1 CARTON (71699-104-56) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 71699-202-28 |
71699-202 |
HUMAN PRESCRIPTION DRUG |
Xcopri Titration Pack |
cenobamate |
KIT |
ORAL |
20200312 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
|
|
1 KIT in 1 CARTON (71699-202-28) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 71699-103-56 |
71699-103 |
HUMAN PRESCRIPTION DRUG |
Xcopri Maintenance Pack |
cenobamate |
KIT |
ORAL |
20200312 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
|
|
1 KIT in 1 CARTON (71699-103-56) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 71699-201-28 |
71699-201 |
HUMAN PRESCRIPTION DRUG |
Xcopri Titration Pack |
cenobamate |
KIT |
ORAL |
20200312 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
|
|
1 KIT in 1 CARTON (71699-201-28) * 1 TABLET in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK |
| 71699-100-30 |
71699-100 |
HUMAN PRESCRIPTION DRUG |
Xcopri |
cenobamate |
TABLET, FILM COATED |
ORAL |
20200312 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
CENOBAMATE |
100 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (71699-100-30) |
| 71699-200-30 |
71699-200 |
HUMAN PRESCRIPTION DRUG |
Xcopri |
cenobamate |
TABLET, FILM COATED |
ORAL |
20200312 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
CENOBAMATE |
200 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (71699-200-30) |
| 71699-050-30 |
71699-050 |
HUMAN PRESCRIPTION DRUG |
Xcopri |
cenobamate |
TABLET, FILM COATED |
ORAL |
20210430 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
CENOBAMATE |
50 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (71699-050-30) |
| 71699-050-99 |
71699-050 |
HUMAN PRESCRIPTION DRUG |
Xcopri |
cenobamate |
TABLET, FILM COATED |
ORAL |
20210430 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
CENOBAMATE |
50 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (71699-050-99) |
| 71699-150-30 |
71699-150 |
HUMAN PRESCRIPTION DRUG |
Xcopri |
cenobamate |
TABLET, FILM COATED |
ORAL |
20200312 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
CENOBAMATE |
150 mg/1 |
30 TABLET, FILM COATED in 1 BOTTLE (71699-150-30) |
| 71699-203-28 |
71699-203 |
HUMAN PRESCRIPTION DRUG |
Xcopri Titration Pack |
cenobamate |
KIT |
ORAL |
20200312 |
N/A |
NDA |
NDA212839 |
SK Life Science, Inc. |
|
|
1 KIT in 1 CARTON (71699-203-28) * 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 TABLET, FILM COATED in 1 BLISTER PACK |