Application 202032
- 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 |
|---|
| 63629-5014 | Lamivudine | Lamivudine | Bryant Ranch Prepack | ANDA | Current |
| 65862-552 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-552 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-552 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-553 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-553 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-553 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 70518-0690 | Lamivudine | Lamivudine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0690 | Lamivudine | Lamivudine | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43378 | ORIG | 2012-01-27 |