Application 214124
- Type
- ANDA
- Sponsor
- AMRING PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET, ORALLY DISINTEGRATING;ORAL | 25MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET, ORALLY DISINTEGRATING;ORAL | 50MG | No | No |
| 003 | LAMOTRIGINE | LAMOTRIGINE | TABLET, ORALLY DISINTEGRATING;ORAL | 100MG | No | No |
| 004 | LAMOTRIGINE | LAMOTRIGINE | TABLET, ORALLY DISINTEGRATING;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69918-350 | Lamotrigine | Lamotrigine | Amring Pharmaceuticals Inc. | ANDA | Current |
| 69918-360 | Lamotrigine | Lamotrigine | Amring Pharmaceuticals Inc. | ANDA | Current |
| 69918-370 | Lamotrigine | Lamotrigine | Amring Pharmaceuticals Inc. | ANDA | Current |
| 69918-380 | Lamotrigine | Lamotrigine | Amring Pharmaceuticals Inc. | ANDA | Current |