Application 205103
- Type
- NDA
- Sponsor
- GENUS LIFESCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | YOSPRALA | ASPIRIN; OMEPRAZOLE | TABLET, DELAYED RELEASE;ORAL | 81MG;40MG | Yes | No |
| 002 | YOSPRALA | ASPIRIN; OMEPRAZOLE | TABLET, DELAYED RELEASE;ORAL | 325MG;40MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 64950-424 | Yosprala | aspirin and omeprazole | Genus Lifesciences Inc. | NDA | Current |
| 64950-424 | Yosprala | aspirin and omeprazole | Genus Lifesciences Inc. | NDA | Current |
| 64950-424 | Yosprala | aspirin and omeprazole | Genus Lifesciences Inc. | NDA | Current |
| 64950-424 | Yosprala | aspirin and omeprazole | Genus Lifesciences Inc. | NDA | Current |
| 64950-425 | Yosprala | aspirin and omeprazole | Genus Lifesciences Inc. | NDA | Current |
| 64950-425 | Yosprala | aspirin and omeprazole | Genus Lifesciences Inc. | NDA | Current |
| 64950-425 | Yosprala | aspirin and omeprazole | Genus Lifesciences Inc. | NDA | Current |
| 64950-425 | Yosprala | aspirin and omeprazole | Genus Lifesciences Inc. | NDA | Current |
| 68071-5102 | Yosprala | Yosprala | NuCare Pharmaceuticals,Inc. | NDA | Current |
| 68071-5102 | Yosprala | Yosprala | NuCare Pharmaceuticals,Inc. | NDA | Current |
| 69597-348 | ASPIRIN/OMEPRAZOLE | aspirin and omeprazole | Basiem | NDA | Current |
| 70347-081 | YOSPRALA | Aspirin and Omeprazole | Aralez Pharmaceuticals Us Inc. | NDA | Current |
| 70347-325 | YOSPRALA | Aspirin and Omeprazole | Aralez Pharmaceuticals Us Inc. | NDA | Current |
| 71800-012 | Yosprala | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-012 | Yosprala | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-012 | Yosprala | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-014 | aspirin and omeprazole delayed-release tab | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-014 | aspirin and omeprazole delayed-release tab | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-014 | aspirin and omeprazole delayed-release tab | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-016 | Yosprala | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-016 | Yosprala | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-016 | Yosprala | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-018 | aspirin and omeprazole delayed-release tab | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-018 | aspirin and omeprazole delayed-release tab | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 71800-018 | aspirin and omeprazole delayed-release tab | aspirin and omeprazole | Innovida Phamaceutique Corporation | NDA | Current |
| 73457-415 | aspirin and omeprazole delayed-release tab | aspirin and omeprazole | Innovida Therapeutique Corporation | NDA | Current |
| 73568-004 | Yosprala | aspirin and omeprazole | PHARMACEUTIKA LTD | NDA | Current |
| 73568-005 | Yosprala | aspirin and omeprazole | PHARMACEUTIKA LTD | NDA | Current |