Application 210649
- Type
- NDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-362 | efavirenz, lamivudine and tenofovir disoproxil fumarate | efavirenz, lamivudine and tenofovir disoproxil fumarate | Macleods Pharmaceuticals Limited | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 60158 | ORIG | 2019-09-30 |
| 58032 | ORIG | 2019-03-19 |
| 58031 | ORIG | 2019-03-19 |
| 62977 | ORIG | 1900-01-01 |
| 62976 | ORIG | 1900-01-01 |