Application 204968
- Type
- ANDA
- Sponsor
- HEC PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 250MG | No | No |
| 002 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 500MG | No | No |
| 003 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 750MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48792-7814 | levofloxacin | levofloxacin | Sunshine Lake Pharma CO., LTD. | ANDA | Current |
| 48792-7815 | levofloxacin | levofloxacin | Sunshine Lake Pharma CO., LTD. | ANDA | Current |
| 48792-7816 | levofloxacin | levofloxacin | Sunshine Lake Pharma CO., LTD. | ANDA | Current |