Application 079099
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET, CHEWABLE;ORAL | 5MG | No | No |
| 002 | 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 |
|---|
| 68462-228 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-228 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-228 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-228 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-228 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-228 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-229 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-229 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-229 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-229 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-229 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-229 | Lamotrigine | Lamotrigine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9222 | ORIG | 2012-02-14 |
| 44400 | ORIG | 2009-03-03 |