Application 205517
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LINEZOLID | LINEZOLID | TABLET;ORAL | 600MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6553 | Linezolid | Linezolid | Major Pharmaceuticals | ANDA | Current |
| 0904-6553 | Linezolid | Linezolid | Major Pharmaceuticals | ANDA | Current |
| 0904-6553 | Linezolid | Linezolid | Major Pharmaceuticals | ANDA | Current |
| 50268-471 | Linezolid | Linezolid | AvPAK | ANDA | Current |
| 50268-471 | Linezolid | Linezolid | AvPAK | ANDA | Current |
| 50268-471 | Linezolid | Linezolid | AvPAK | ANDA | Current |
| 60687-189 | Linezolid | Linezolid | American Health Packaging | ANDA | Current |
| 67877-419 | Linezolid | Linezolid | Ascend Laboratories, LLC | ANDA | Current |
| 67877-419 | Linezolid | Linezolid | Ascend Laboratories, LLC | ANDA | Current |
| 67877-419 | Linezolid | Linezolid | Ascend Laboratories, LLC | ANDA | Current |
| 67877-419 | Linezolid | Linezolid | Ascend Laboratories, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32682 | ORIG | 2015-09-01 |