Application 077695
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAMIVUDINE | LAMIVUDINE | SOLUTION;ORAL | 10MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57237-274 | Lamivudine | Lamivudine | Rising Health, LLC | ANDA | Current |
| 57237-274 | Lamivudine | Lamivudine | Rising Health, LLC | ANDA | Current |
| 57237-274 | Lamivudine | Lamivudine | Rising Health, LLC | ANDA | Current |
| 57237-274 | Lamivudine | Lamivudine | Rising Health, LLC | ANDA | Current |
| 57237-274 | Lamivudine | Lamivudine | Rising Health, LLC | ANDA | Current |
| 65862-055 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-055 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-055 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-055 | Lamivudine | Lamivudine | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31279 | ORIG | 2005-11-18 |