Application 200560
- Type
- ANDA
- Sponsor
- MYLAN ASI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOFLOXACIN | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) | No | No |
| 002 | LEVOFLOXACIN | LEVOFLOXACIN | INJECTABLE;INJECTION | EQ 750MG/30ML (EQ 25MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-130 | Levofloxacin | levofloxacin | Sagent Pharmaceuticals | ANDA | Current |