Application 090198
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAMIVUDINE | LAMIVUDINE | TABLET;ORAL | 150MG | No | No |
| 002 | LAMIVUDINE | LAMIVUDINE | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-001 | Lamivudine | Lamivudine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-001 | Lamivudine | Lamivudine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-001 | Lamivudine | Lamivudine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-001 | Lamivudine | Lamivudine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-002 | Lamivudine | Lamivudine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-002 | Lamivudine | Lamivudine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-002 | Lamivudine | Lamivudine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-002 | Lamivudine | Lamivudine | Macleods Pharmaceuticals Limited | ANDA | Current |
| 70518-3267 | Lamivudine | Lamivudine | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31455 | ORIG | 2008-10-09 |