Application 206829
- Type
- NDA
- Sponsor
- CUBIST PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZERBAXA | CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM | POWDER;INTRAVENOUS | EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67919-030 | ZERBAXA | ceftolozane and tazobactam | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-030 | ZERBAXA | ceftolozane and tazobactam | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-030 | ZERBAXA | ceftolozane and tazobactam | Merck Sharp & Dohme LLC | NDA | Current |
| 67919-030 | ZERBAXA | ceftolozane and tazobactam | Merck Sharp & Dohme LLC | NDA | Current |
| 67919-030 | ZERBAXA | ceftolozane and tazobactam | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-030 | ZERBAXA | ceftolozane and tazobactam | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-030 | ZERBAXA | ceftolozane and tazobactam | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-030 | ZERBAXA | ceftolozane and tazobactam | Merck Sharp & Dohme Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85934 | SUPPL | 2026-05-18 |
| 85902 | SUPPL | 2026-05-13 |
| 72840 | SUPPL | 2022-12-09 |
| 70805 | SUPPL | 2022-04-22 |
| 70804 | SUPPL | 2022-04-22 |
| 70803 | SUPPL | 2022-04-22 |
| 70802 | SUPPL | 2022-04-22 |
| 61310 | SUPPL | 2019-12-17 |
| 61278 | SUPPL | 2019-12-16 |
| 58976 | SUPPL | 2019-06-05 |
| 58975 | SUPPL | 2019-06-05 |
| 45768 | SUPPL | 2016-11-01 |
| 45697 | SUPPL | 2016-10-28 |
| 45241 | SUPPL | 2016-09-06 |
| 45237 | SUPPL | 2016-09-06 |
| 10598 | SUPPL | 2015-05-22 |
| 40567 | SUPPL | 2015-05-20 |
| 44950 | ORIG | 2015-01-27 |
| 23026 | ORIG | 2015-01-27 |
| 10597 | ORIG | 2014-12-23 |
| 40566 | ORIG | 2014-12-22 |