Application 076093
- Type
- ANDA
- Sponsor
- LARKEN LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OFLOXACIN | OFLOXACIN | TABLET;ORAL | 200MG | No | No |
| 002 | OFLOXACIN | OFLOXACIN | TABLET;ORAL | 300MG | No | No |
| 003 | OFLOXACIN | OFLOXACIN | TABLET;ORAL | 400MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68047-713 | ofloxacin | ofloxacin | Larken Laboratories, Inc. | ANDA | Current |
| 68047-713 | ofloxacin | ofloxacin | Larken Laboratories, Inc. | ANDA | Current |
| 68047-713 | ofloxacin | ofloxacin | Larken Laboratories, Inc. | ANDA | Current |
| 68047-713 | ofloxacin | ofloxacin | Larken Laboratories, Inc. | ANDA | Current |
| 68047-713 | ofloxacin | ofloxacin | Larken Laboratories, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31074 | ORIG | 2003-04-16 |