Application 078009
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET, CHEWABLE; ORAL | 2MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET, CHEWABLE;ORAL | 5MG | No | No |
| 003 | LAMOTRIGINE | LAMOTRIGINE | TABLET, CHEWABLE;ORAL | 25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65841-689 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-689 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-689 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-689 | Lamotrigine | Lamotrigine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-690 | Lamotrigine | Lamotrigine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-690 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-690 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-690 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 68382-108 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-108 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-108 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-108 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-108 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-108 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-109 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-109 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-109 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-109 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-109 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-109 | Lamotrigine | Lamotrigine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22617 | ORIG | 2012-02-14 |