Application 208744
- Type
- NDA
- Sponsor
- ACCORD HLTHCARE INC
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 |
|---|
| 16729-364 | TIGECYCLINE | TIGECYCLINE | Accord Healthcare Inc. | NDA | Current |
| 16729-364 | TIGECYCLINE | TIGECYCLINE | Accord Healthcare Inc. | NDA | Current |
| 16729-364 | TIGECYCLINE | TIGECYCLINE | Accord Healthcare Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81860 | SUPPL | 2025-04-08 |
| 81804 | SUPPL | 2025-04-02 |
| 65006 | SUPPL | 2020-10-23 |
| 64982 | SUPPL | 2020-10-23 |
| 55856 | ORIG | 2018-10-10 |
| 51866 | ORIG | 2018-01-26 |
| 51089 | ORIG | 2018-01-18 |