Application 209387
- Type
- NDA
- Sponsor
- EXELA PHARMA SCS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 50MG/100ML (0.5MG/ML) | Yes | Yes |
| 002 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 10MG/50ML (0.2MG/ML) | Yes | No |
| 003 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 20MG/100ML (0.2MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51754-1006 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1006 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1018 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1018 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1029 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-1029 | NIPRIDE RTU | Sodium Nitroprusside | EXELA PHARMA SCIENCES, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68023 | SUPPL | 2021-07-07 |
| 54341 | SUPPL | 2018-05-25 |
| 54334 | SUPPL | 2018-05-24 |
| 49519 | ORIG | 2017-08-23 |
| 47545 | ORIG | 2017-03-14 |
| 47516 | ORIG | 2017-03-09 |