Application 090169
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 25MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 100MG | No | No |
| 003 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 150MG | No | No |
| 004 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68462-243 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-244 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-245 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-246 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |