| 69097-031-91 |
69097-031 |
HUMAN PRESCRIPTION DRUG |
Nilotinib |
Nilotinib |
CAPSULE |
ORAL |
20250618 |
N/A |
NDA |
NDA218922 |
Cipla USA Inc. |
NILOTINIB |
150 mg/1 |
4 CARTON in 1 CARTON (69097-031-91) / 2 BLISTER PACK in 1 CARTON (69097-031-73) / 14 CAPSULE in 1 BLISTER PACK (69097-031-76) |
| 69097-032-74 |
69097-032 |
HUMAN PRESCRIPTION DRUG |
Nilotinib |
Nilotinib |
CAPSULE |
ORAL |
20250618 |
N/A |
NDA |
NDA218922 |
Cipla USA Inc. |
NILOTINIB |
200 mg/1 |
4 CARTON in 1 CARTON (69097-032-74) / 4 BLISTER PACK in 1 CARTON (69097-032-56) / 7 CAPSULE in 1 BLISTER PACK (69097-032-17) |
| 69097-032-91 |
69097-032 |
HUMAN PRESCRIPTION DRUG |
Nilotinib |
Nilotinib |
CAPSULE |
ORAL |
20250618 |
N/A |
NDA |
NDA218922 |
Cipla USA Inc. |
NILOTINIB |
200 mg/1 |
4 CARTON in 1 CARTON (69097-032-91) / 2 BLISTER PACK in 1 CARTON (69097-032-73) / 14 CAPSULE in 1 BLISTER PACK (69097-032-76) |
| 69097-031-74 |
69097-031 |
HUMAN PRESCRIPTION DRUG |
Nilotinib |
Nilotinib |
CAPSULE |
ORAL |
20250618 |
N/A |
NDA |
NDA218922 |
Cipla USA Inc. |
NILOTINIB |
150 mg/1 |
4 CARTON in 1 CARTON (69097-031-74) / 4 BLISTER PACK in 1 CARTON (69097-031-56) / 7 CAPSULE in 1 BLISTER PACK (69097-031-17) |
| 69097-030-63 |
69097-030 |
HUMAN PRESCRIPTION DRUG |
Nilotinib |
Nilotinib |
CAPSULE |
ORAL |
20250618 |
N/A |
NDA |
NDA218922 |
Cipla USA Inc. |
NILOTINIB |
50 mg/1 |
7 BLISTER PACK in 1 CARTON (69097-030-63) / 4 CAPSULE in 1 BLISTER PACK (69097-030-16) |
| 69097-030-08 |
69097-030 |
HUMAN PRESCRIPTION DRUG |
Nilotinib |
Nilotinib |
CAPSULE |
ORAL |
20250618 |
N/A |
NDA |
NDA218922 |
Cipla USA Inc. |
NILOTINIB |
50 mg/1 |
120 CAPSULE in 1 BOTTLE, PLASTIC (69097-030-08) |
| 76282-788-12 |
76282-788 |
HUMAN PRESCRIPTION DRUG |
Nilotinib |
Nilotinib |
CAPSULE |
ORAL |
20251114 |
N/A |
NDA |
NDA218922 |
EXELAN PHARMACEUTICALS INC. |
NILOTINIB |
50 mg/1 |
120 CAPSULE in 1 BOTTLE, PLASTIC (76282-788-12) |
| 76282-789-58 |
76282-789 |
HUMAN PRESCRIPTION DRUG |
Nilotinib |
Nilotinib |
CAPSULE |
ORAL |
20251114 |
N/A |
NDA |
NDA218922 |
EXELAN PHARMACEUTICALS INC. |
NILOTINIB |
150 mg/1 |
4 CARTON in 1 CARTON (76282-789-58) / 4 BLISTER PACK in 1 CARTON (76282-789-46) / 7 CAPSULE in 1 BLISTER PACK (76282-789-45) |
| 76282-790-58 |
76282-790 |
HUMAN PRESCRIPTION DRUG |
Nilotinib |
Nilotinib |
CAPSULE |
ORAL |
20251114 |
N/A |
NDA |
NDA218922 |
EXELAN PHARMACEUTICALS INC. |
NILOTINIB |
200 mg/1 |
4 CARTON in 1 CARTON (76282-790-58) / 4 BLISTER PACK in 1 CARTON (76282-790-46) / 7 CAPSULE in 1 BLISTER PACK (76282-790-45) |