Application 210278
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | No | No |
| 002 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 003 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 004 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 005 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68462-370 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-370 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-370 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-370 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-371 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-371 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-371 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-371 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-372 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-372 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-372 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-372 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-373 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-373 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-373 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-373 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-374 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-374 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-374 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-374 | TOPIRAMATE | topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 72603-120 | TOPIRAMATE | topiramate | NorthStar RxLLC | ANDA | Current |
| 72603-121 | TOPIRAMATE | topiramate | NorthStar RxLLC | ANDA | Current |
| 72603-122 | TOPIRAMATE | topiramate | NorthStar RxLLC | ANDA | Current |
| 72603-123 | TOPIRAMATE | topiramate | NorthStar RxLLC | ANDA | Current |
| 72603-124 | TOPIRAMATE | topiramate | NorthStar RxLLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57744 | ORIG | 2019-02-21 |