Application 022509
- Type
- NDA
- Sponsor
- SMITHKLINE BEECHAM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE; ORAL | 25MG | No | No |
| 002 | LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE; ORAL | 50MG | No | No |
| 003 | LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE; ORAL | 100MG | No | No |
| 004 | LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE; ORAL | 200MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 60206 | ORIG | 2019-10-02 |
| 44764 | ORIG | 2011-02-17 |
| 22040 | ORIG | 2010-12-01 |
| 29794 | ORIG | 2010-02-17 |
| 38775 | ORIG | 2010-02-16 |
| 53309 | ORIG | 1900-01-01 |
| 53308 | ORIG | 1900-01-01 |