Application 205600
- Type
- ANDA
- Sponsor
- MICRO LABS LTD INDIA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVOFLOXACIN | LEVOFLOXACIN | SOLUTION/DROPS;OPHTHALMIC | 1.5% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42571-168 | LEVOFLOXACIN | Levofloxacin | Micro Labs Limited | ANDA | Current |
| 54288-140 | Levofloxacin | Levofloxacin | BPI LABS LLC | ANDA | Current |
| 54288-140 | Levofloxacin | Levofloxacin | BPI LABS LLC | ANDA | Current |
| 54288-140 | Levofloxacin | Levofloxacin | BPI LABS LLC | ANDA | Current |
| 54288-140 | Levofloxacin | Levofloxacin | BPI LABS LLC | ANDA | Current |
| 54288-140 | Levofloxacin | Levofloxacin | BPI LABS LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57953 | ORIG | 2019-03-12 |