Application 091612
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 300MG | No | No |
| 002 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 150MG | No | No |
| 003 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 200MG | No | No |
| 004 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 250MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7104 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 70518-0918 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0918 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9347 | ORIG | 2015-03-20 |