Details for New Drug Application (NDA): 209387
✉ Email this page to a colleague
The generic ingredient in NIPRIDE RTU IN SODIUM CHLORIDE 0.9% is sodium nitroprusside. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.
Summary for 209387
| Tradename: | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% |
| Applicant: | Exela Pharma |
| Ingredient: | sodium nitroprusside |
| Patents: | 0 |
Pharmacology for NDA: 209387
| Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 209387
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | sodium nitroprusside | SOLUTION;INTRAVENOUS | 209387 | NDA | EXELA PHARMA SCIENCES, LLC | 51754-1006 | 51754-1006-1 | 1 VIAL in 1 VIAL (51754-1006-1) / 100 mL in 1 VIAL |
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | sodium nitroprusside | SOLUTION;INTRAVENOUS | 209387 | NDA | EXELA PHARMA SCIENCES, LLC | 51754-1029 | 51754-1029-1 | 1 VIAL in 1 CARTON (51754-1029-1) / 100 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/100ML (0.5MG/ML) | ||||
| Approval Date: | Mar 8, 2017 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 7, 2017 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/100ML (0.2MG/ML) | ||||
| Approval Date: | Jul 13, 2018 | TE: | AP | RLD: | Yes | ||||
Complete Access Available with Subscription
