Application 090607
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 25MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 100MG | No | No |
| 003 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 150MG | No | No |
| 004 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-274 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-274 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-275 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-275 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-276 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-276 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-277 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-277 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 50090-2992 | Lamotrigine | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 55154-8129 | Lamotrigine | Lamotrigine | Cardinal Health | ANDA | Current |
| 62332-037 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-037 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-037 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-037 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-037 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-037 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-038 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-038 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-038 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-038 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-038 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-038 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-039 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-039 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-039 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-039 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-039 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-039 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-040 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-040 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-040 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-040 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-040 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-040 | Lamotrigine | Lamotrigine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 63739-516 | Lamotrigine | Lamotrigine | McKesson Corporation | ANDA | Current |
| 63739-516 | Lamotrigine | Lamotrigine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-517 | Lamotrigine | Lamotrigine | McKesson Corporation | ANDA | Current |
| 63739-517 | Lamotrigine | Lamotrigine | McKesson Corporation dba SKY Packaging | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9280 | ORIG | 2012-02-14 |