Application 050640
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BACTOCILL IN PLASTIC CONTAINER | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/ML | Yes | Yes |
| 002 | BACTOCILL IN PLASTIC CONTAINER | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 40MG BASE/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-1013 | OXACILLIN | OXACILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1013 | OXACILLIN | OXACILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1013 | OXACILLIN | OXACILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1013 | OXACILLIN | OXACILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1015 | OXACILLIN | OXACILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1015 | OXACILLIN | OXACILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1015 | OXACILLIN | OXACILLIN | Baxter Healthcare Corporation | NDA | Current |
| 0338-1015 | OXACILLIN | OXACILLIN | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 47442 | SUPPL | 2017-03-03 |
| 47339 | SUPPL | 2017-02-27 |
| 30212 | SUPPL | 2015-01-08 |
| 39066 | SUPPL | 2015-01-07 |
| 17966 | SUPPL | 2012-11-28 |
| 7923 | SUPPL | 2012-11-23 |
| 17965 | SUPPL | 2011-10-20 |
| 7922 | SUPPL | 2011-10-17 |
| 17964 | SUPPL | 2008-06-05 |
| 7921 | SUPPL | 2008-04-22 |
| 30211 | SUPPL | 2004-03-24 |
| 7920 | SUPPL | 2002-08-23 |