Application 078767
- Type
- ANDA
- Sponsor
- HIKMA PHARMS
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 |
|---|---|---|---|---|---|
| 0143-9775 | Levofloxacin | Levofloxacin | West-ward Pharmaceutical Corp | ANDA | Current |
| 0143-9776 | Levofloxacin | Levofloxacin | West-ward Pharmaceutical Corp | ANDA | Current |
| 0143-9777 | Levofloxacin | Levofloxacin | West-ward Pharmaceutical Corp | ANDA | Current |
| 59115-095 | Levofloxacin | Levofloxacin | Hikma Pharmaceutical | ANDA | Current |
| 59115-096 | Levofloxacin | Levofloxacin | Hikma Pharmaceutical | ANDA | Current |
| 59115-097 | Levofloxacin | Levofloxacin | Hikma Pharmaceutical | ANDA | Current |