Application 050817
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFEPIME IN PLASTIC CONTAINER | CEFEPIME HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/50ML (EQ 20MG BASE/ML) | Yes | Yes |
| 002 | CEFEPIME IN PLASTIC CONTAINER | CEFEPIME HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2GM BASE/100ML (EQ 20MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-1301 | Cefepime | cefepime | Baxter Healthcare Corporation | NDA | Current |
| 0338-1301 | Cefepime | cefepime | Baxter Healthcare Corporation | NDA | Current |
| 0338-1301 | Cefepime | cefepime | Baxter Healthcare Corporation | NDA | Current |
| 0338-1301 | Cefepime | cefepime | Baxter Healthcare Corporation | NDA | Current |
| 0338-1301 | Cefepime | cefepime | Baxter Healthcare Corporation | NDA | Current |
| 0338-1301 | Cefepime | cefepime | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82994 | SUPPL | 2025-07-31 |
| 82987 | SUPPL | 2025-07-30 |
| 62820 | SUPPL | 2020-05-05 |
| 62814 | SUPPL | 2020-05-04 |
| 39384 | SUPPL | 2016-05-11 |
| 30607 | SUPPL | 2016-05-10 |
| 39383 | SUPPL | 2014-06-10 |
| 8337 | SUPPL | 2014-06-05 |
| 18296 | SUPPL | 2012-09-11 |
| 8338 | SUPPL | 2012-09-10 |
| 18295 | SUPPL | 2010-07-06 |
| 30606 | SUPPL | 2010-07-02 |
| 44789 | ORIG | 2009-12-31 |
| 42752 | ORIG | 2009-12-31 |
| 23729 | ORIG | 2008-09-19 |
| 30605 | ORIG | 2008-08-12 |