Application 077464
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA 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 |
|---|
| 60687-362 | Lamivudine | Lamivudine | American Health Packaging | ANDA | Current |
| 60687-362 | Lamivudine | Lamivudine | American Health Packaging | ANDA | Current |
| 60687-362 | Lamivudine | Lamivudine | American Health Packaging | ANDA | Current |
| 65862-025 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-025 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-025 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-025 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-026 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-026 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-026 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-026 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9049 | ORIG | 2007-10-04 |
| 9048 | ORIG | 2005-06-15 |