Application 091486
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXACILLIN SODIUM | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 002 | OXACILLIN SODIUM | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72485-409 | Oxacillin | Oxacillin | Armas Pharmaceuticals Inc. | ANDA | Current |
| 82449-506 | oxacillin | oxacillin | Steriscience Specialties Private Limited | ANDA | Current |
| 82449-506 | oxacillin | oxacillin | Steriscience Specialties Private Limited | ANDA | Current |
| 82449-506 | oxacillin | oxacillin | Steriscience Specialties Private Limited | ANDA | Current |