Application 204287
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ;EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 600MG;200MG;300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-138 | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Macleods Pharmaceuticals Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10317 | ORIG | 2014-12-30 |