Application 202498
- Type
- ANDA
- Sponsor
- WOCKHARDT LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 25MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 003 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 004 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 005 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55648-271 | Lamotrigine | Lamotrigine | Wockhardt Limited | ANDA | Current |
| 55648-272 | Lamotrigine | Lamotrigine | Wockhardt Limited | ANDA | Current |
| 55648-273 | Lamotrigine | Lamotrigine | Wockhardt Limited | ANDA | Current |
| 55648-274 | Lamotrigine | Lamotrigine | Wockhardt Limited | ANDA | Current |
| 55648-275 | Lamotrigine | Lamotrigine | Wockhardt Limited | ANDA | Current |
| 64679-271 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-271 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-271 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-272 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-272 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-272 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-273 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-273 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-273 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-274 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-274 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-274 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-275 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-275 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |
| 64679-275 | Lamotrigine | Lamotrigine | Wockhardt USA LLC. | ANDA | Current |