Application 209817
- Type
- NDA
- Sponsor
- PARATEK PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NUZYRA | OMADACYCLINE TOSYLATE | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71715-001 | NUZYRA | omadacycline | Paratek Pharmaceuticals, Inc. | NDA | Current |
| 71715-001 | NUZYRA | omadacycline | Paratek Pharmaceuticals, Inc. | NDA | Current |
| 71715-001 | NUZYRA | omadacycline | Paratek Pharmaceuticals, Inc. | NDA | Current |
| 71715-001 | NUZYRA | omadacycline | Paratek Pharmaceuticals, Inc. | NDA | Current |
| 71715-001 | NUZYRA | omadacycline | Paratek Pharmaceuticals, Inc. | NDA | Current |
| 71715-001 | NUZYRA | omadacycline | Paratek Pharmaceuticals, Inc. | NDA | Current |
| 71715-001 | NUZYRA | omadacycline | Paratek Pharmaceuticals, Inc. | NDA | Current |