Application 202383
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| 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 |
| 006 | LAMOTRIGINE | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 250MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-623 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-623 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-623 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-623 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-624 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-624 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-624 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-624 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-625 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-625 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-625 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-625 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-626 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-626 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-626 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-626 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-627 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-627 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-627 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-627 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-893 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-893 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-893 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 16714-893 | Lamotrigine | Lamotrigine | NorthStar Rx LLC | ANDA | Current |
| 55111-419 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-419 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-419 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-419 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-419 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-428 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-428 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-428 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-428 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-428 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-717 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-717 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-717 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-717 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-717 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-718 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-718 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-718 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-718 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-718 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-719 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-719 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-719 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-719 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-719 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-720 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-720 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-720 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-720 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-720 | Lamotrigine | Lamotrigine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 63629-8283 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8283 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 68788-6868 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6868 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6868 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6868 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6868 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |