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Application 208627
- Type
- NDA
- Sponsor
- SIGA TECHNOLOGIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TPOXX | TECOVIRIMAT | CAPSULE;ORAL | 200MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50072-200 | TPOXX | tecovirimat monohydrate | SIGA Technologies, Inc. | NDA | Current |
| 50072-200 | TPOXX | tecovirimat monohydrate | SIGA Technologies, Inc. | NDA | Current |
| 50072-200 | TPOXX | tecovirimat monohydrate | SIGA Technologies, Inc. | NDA | Current |
| 50072-200 | TPOXX | tecovirimat monohydrate | SIGA Technologies, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81642 | SUPPL | 2025-03-19 |
| 78627 | SUPPL | 2024-07-02 |
| 78625 | SUPPL | 2024-06-04 |
| 71096 | SUPPL | 2022-05-19 |
| 71094 | SUPPL | 2022-05-19 |
| 69454 | SUPPL | 2021-12-02 |
| 69404 | SUPPL | 2021-11-24 |
| 55177 | ORIG | 2018-08-15 |
| 54885 | ORIG | 2018-07-13 |
| 54884 | ORIG | 2018-07-13 |