Application 205435
- Type
- NDA
- Sponsor
- CUBIST PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SIVEXTRO | TEDIZOLID PHOSPHATE | TABLET;ORAL | 200MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67919-041 | SIVEXTRO | tedizolid phosphate | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-041 | SIVEXTRO | tedizolid phosphate | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-041 | SIVEXTRO | tedizolid phosphate | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-041 | SIVEXTRO | tedizolid phosphate | Merck Sharp & Dohme LLC | NDA | Current |
| 67919-041 | SIVEXTRO | tedizolid phosphate | Merck Sharp & Dohme LLC | NDA | Current |
| 67919-041 | SIVEXTRO | tedizolid phosphate | Merck Sharp & Dohme LLC | NDA | Current |
| 67919-041 | SIVEXTRO | tedizolid phosphate | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-041 | SIVEXTRO | tedizolid phosphate | Merck Sharp & Dohme Corp. | NDA | Current |
| 67919-041 | SIVEXTRO | tedizolid phosphate | Merck Sharp & Dohme Corp. | NDA | Current |
| 72000-310 | SIVEXTRO | tedizolid phosphate | Nabriva Therapeutics US, Inc. | NDA | Current |
| 72000-310 | SIVEXTRO | tedizolid phosphate | Nabriva Therapeutics US, Inc. | NDA | Current |
| 72000-310 | SIVEXTRO | tedizolid phosphate | Nabriva Therapeutics US, Inc. | NDA | Current |
| 72000-310 | SIVEXTRO | tedizolid phosphate | Nabriva Therapeutics US, Inc. | NDA | Current |
| 72000-310 | SIVEXTRO | tedizolid phosphate | Nabriva Therapeutics US, Inc. | NDA | Current |
| 72000-310 | SIVEXTRO | tedizolid phosphate | Nabriva Therapeutics US, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85275 | SUPPL | 2026-03-06 |
| 85206 | SUPPL | 2026-03-03 |
| 81884 | SUPPL | 2025-04-08 |
| 81827 | SUPPL | 2025-04-07 |
| 69354 | SUPPL | 2021-11-18 |
| 69346 | SUPPL | 2021-11-18 |
| 65028 | SUPPL | 2020-10-27 |
| 65015 | SUPPL | 2020-10-23 |
| 63675 | SUPPL | 2020-06-23 |
| 63660 | SUPPL | 2020-06-22 |
| 59958 | SUPPL | 2019-09-11 |
| 59960 | SUPPL | 2019-09-10 |
| 57932 | SUPPL | 2019-03-08 |
| 57922 | SUPPL | 2019-03-07 |
| 49477 | SUPPL | 2017-08-21 |
| 49475 | SUPPL | 2017-08-21 |
| 49433 | SUPPL | 2017-08-16 |
| 49430 | SUPPL | 2017-08-16 |
| 45802 | SUPPL | 2016-11-04 |
| 45737 | SUPPL | 2016-10-31 |
| 45408 | SUPPL | 2016-09-28 |
| 45282 | SUPPL | 2016-09-19 |
| 10448 | SUPPL | 2016-06-07 |
| 40469 | SUPPL | 2015-03-09 |
| 32676 | SUPPL | 2015-03-06 |
| 44918 | ORIG | 2014-07-16 |
| 22989 | ORIG | 2014-07-16 |
| 40468 | ORIG | 2014-06-23 |
| 32675 | ORIG | 2014-06-23 |