Skip to contentApplication 200694
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67877-164 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-164 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-164 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-165 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-165 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-165 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-166 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-166 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-166 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-167 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-167 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-167 | Lamotrigine | Lamotrigine | Ascend Laboratories, LLC | ANDA | Current |