Application 200250
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
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 |
|---|---|---|---|---|---|
| 68462-326 | Levofloxacin | Levofloxacin | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-327 | Levofloxacin | Levofloxacin | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-328 | Levofloxacin | Levofloxacin | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |