Application 209550
- Type
- ANDA
- Sponsor
- CASI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42385-901 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | Laurus Labs Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53557 | ORIG | 2018-03-30 |