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Application 205555
- Type
- NDA
- Sponsor
- NOVATECH SA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | STERITALC | TALC | POWDER;INTRAPLEURAL | 2GM/VIAL | Yes | No |
| 002 | STERITALC | TALC | POWDER;INTRAPLEURAL | 3GM/VIAL | Yes | No |
| 003 | STERITALC | TALC | POWDER;INTRAPLEURAL | 4GM/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62327-222 | Steritalc | Talc | Novatech SA | NDA | Current |
| 62327-222 | Steritalc | Talc | Novatech SA | NDA | Current |
| 62327-333 | Steritalc | Talc | Novatech SA | NDA | Current |
| 62327-333 | Steritalc | Talc | Novatech SA | NDA | Current |
| 62327-444 | Steritalc | Talc | Novatech SA | NDA | Current |
| 62327-444 | Steritalc | Talc | Novatech SA | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82543 | SUPPL | 2025-06-12 |
| 82532 | SUPPL | 2025-06-11 |
| 49867 | ORIG | 2017-09-27 |
| 48284 | ORIG | 2017-05-08 |
| 48236 | ORIG | 2017-05-04 |