Application 203613
- Type
- ANDA
- Sponsor
- JUBILANT 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59746-513 | Levofloxacin | levofloxacin | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-513 | Levofloxacin | levofloxacin | Jubilant Cadista Pharmace | ANDA | Current |
| 59746-514 | Levofloxacin | levofloxacin | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-514 | Levofloxacin | levofloxacin | Jubilant Cadista Pharmace | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10240 | ORIG | 2015-06-22 |