Application 205645
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIGECYCLINE | TIGECYCLINE | POWDER;INTRAVENOUS | 50MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-960 | Tigecycline | Tigecycline | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-960 | Tigecycline | Tigecycline | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81857 | SUPPL | 2025-04-08 |
| 81805 | SUPPL | 2025-04-02 |
| 65253 | SUPPL | 2020-11-17 |
| 65247 | SUPPL | 2020-11-16 |
| 58233 | SUPPL | 2019-04-05 |
| 58226 | SUPPL | 2019-04-05 |
| 49571 | SUPPL | 2017-08-29 |
| 49451 | SUPPL | 2017-08-17 |
| 48852 | ORIG | 2017-06-28 |
| 32699 | ORIG | 2016-12-06 |
| 46014 | ORIG | 2016-12-05 |