Application 213038
- Type
- ANDA
- Sponsor
- LAURUS LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 400MG;300MG;300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42385-929 | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | Laurus Labs Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63454 | ORIG | 2020-06-08 |