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Application 214518
- Type
- NDA
- Sponsor
- SIGA TECHNOLOGIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TPOXX | TECOVIRIMAT | SOLUTION;INTRAVENOUS | 200MG/20ML (10MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50072-010 | TPOXX | tecovirimat monohydrate | SIGA Technologies, Inc. | NDA | Current |
| 50072-010 | TPOXX | tecovirimat monohydrate | SIGA Technologies, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78628 | SUPPL | 2024-07-02 |
| 78626 | SUPPL | 2024-06-04 |
| 71846 | ORIG | 2022-08-18 |
| 71105 | ORIG | 2022-05-20 |
| 71097 | ORIG | 2022-05-19 |