Application 205833
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | MOXIFLOXACIN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 400MG/250ML (1.6MG/ML) | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67457-323 | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | Mylan Institutional LLC | ANDA | Current |
| 67457-323 | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | Mylan Institutional LLC | ANDA | Current |
| 67457-323 | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | Mylan Institutional LLC | ANDA | Current |