Details for New Drug Application (NDA): 209387
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The generic ingredient in NIPRIDE RTU IN SODIUM CHLORIDE 0.9% is sodium nitroprusside. There are one thousand four hundred and seventy-two drug master file entries for this compound. Sixteen 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| Strength | 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
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