| 68382-863-05 |
68382-863 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
25 mg/1 |
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-05) |
| 68382-863-06 |
68382-863 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
25 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-06) |
| 68382-863-16 |
68382-863 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
25 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-16) |
| 68382-863-78 |
68382-863 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
25 mg/1 |
3 BLISTER PACK in 1 CARTON (68382-863-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30) |
| 68382-358-01 |
68382-358 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20231113 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
200 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-01) |
| 68382-358-05 |
68382-358 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20231113 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
200 mg/1 |
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-05) |
| 68382-358-06 |
68382-358 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20231113 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
200 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-358-06) |
| 68382-358-78 |
68382-358 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20231113 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
200 mg/1 |
3 BLISTER PACK in 1 CARTON (68382-358-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-358-30) |
| 68382-769-01 |
68382-769 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
100 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-01) |
| 68382-769-05 |
68382-769 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
100 mg/1 |
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-05) |
| 68382-769-06 |
68382-769 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
100 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-06) |
| 68382-769-16 |
68382-769 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
100 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-769-16) |
| 68382-769-78 |
68382-769 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
100 mg/1 |
3 BLISTER PACK in 1 CARTON (68382-769-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-769-30) |
| 68382-864-01 |
68382-864 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
50 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-01) |
| 68382-864-05 |
68382-864 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
50 mg/1 |
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-05) |
| 68382-864-06 |
68382-864 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
50 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-06) |
| 68382-864-16 |
68382-864 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
50 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-864-16) |
| 68382-864-78 |
68382-864 |
HUMAN PRESCRIPTION DRUG |
Topiramate |
Topiramate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20240910 |
N/A |
ANDA |
ANDA207382 |
Zydus Pharmaceuticals USA Inc. |
TOPIRAMATE |
50 mg/1 |
3 BLISTER PACK in 1 CARTON (68382-864-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-864-30) |