Application 213271
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
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 |
|---|---|---|---|---|---|
| 27241-183 | Lamotrigine | Lamotrigine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-183 | Lamotrigine | Lamotrigine | Ajanta Pharma Limited | ANDA | Current |
| 27241-183 | Lamotrigine | Lamotrigine | Ajanta Pharma Limited | ANDA | Current |
| 27241-184 | Lamotrigine | Lamotrigine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-184 | Lamotrigine | Lamotrigine | Ajanta Pharma Limited | ANDA | Current |
| 27241-184 | Lamotrigine | Lamotrigine | Ajanta Pharma Limited | ANDA | Current |
| 27241-185 | Lamotrigine | Lamotrigine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-185 | Lamotrigine | Lamotrigine | Ajanta Pharma Limited | ANDA | Current |
| 27241-185 | Lamotrigine | Lamotrigine | Ajanta Pharma Limited | ANDA | Current |
| 27241-186 | Lamotrigine | Lamotrigine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-186 | Lamotrigine | Lamotrigine | Ajanta Pharma Limited | ANDA | Current |
| 27241-186 | Lamotrigine | Lamotrigine | Ajanta Pharma Limited | ANDA | Current |