Application 205006
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LACOSAMIDE | LACOSAMIDE | TABLET;ORAL | 50MG | No | No |
| 002 | LACOSAMIDE | LACOSAMIDE | TABLET;ORAL | 100MG | No | No |
| 003 | LACOSAMIDE | LACOSAMIDE | TABLET;ORAL | 150MG | No | No |
| 004 | LACOSAMIDE | LACOSAMIDE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68462-678 | lacosamide | lacosamide | Glenmark Pharmaceuticals Inc. USA | ANDA | Current |
| 68462-678 | lacosamide | lacosamide | Glenmark Pharmaceuticals Inc. USA | ANDA | Current |
| 68462-679 | lacosamide | lacosamide | Glenmark Pharmaceuticals Inc. USA | ANDA | Current |
| 68462-679 | lacosamide | lacosamide | Glenmark Pharmaceuticals Inc. USA | ANDA | Current |
| 68462-680 | lacosamide | lacosamide | Glenmark Pharmaceuticals Inc. USA | ANDA | Current |
| 68462-680 | lacosamide | lacosamide | Glenmark Pharmaceuticals Inc. USA | ANDA | Current |
| 68462-681 | lacosamide | lacosamide | Glenmark Pharmaceuticals Inc. USA | ANDA | Current |
| 68462-681 | lacosamide | lacosamide | Glenmark Pharmaceuticals Inc. USA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32612 | ORIG | 2015-10-30 |