Application 076420
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET, CHEWABLE;ORAL | 5MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET, CHEWABLE;ORAL | 25MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-0132 | Lamotrigine | Lamotrigine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0688 | Lamotrigine | Lamotrigine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 42291-353 | Lamotrigine | Lamotrigine | AvKARE, Inc. | ANDA | Current |
| 42291-354 | Lamotrigine | Lamotrigine | AvKARE, Inc. | ANDA | Current |
| 68151-4249 | Lamotrigine | Lamotrigine | Carilion Materials Management | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31119 | ORIG | 2008-06-28 |