Details for New Drug Application (NDA): 215846
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NDA 215846 describes SODIUM NITROPRUSSIDE, which is a drug marketed by Abraxis Pharm, Amneal, Amphastar Pharms Inc, Avet Lifesciences, Baxter Hlthcare, Be Pharms, Caplin, Chartwell Rx, Cipla, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Hainan Poly Pharm, Micro Labs, Mylan Labs Ltd, Nexus, Norvium Bioscience, Sagent Pharms Inc, Somerset Theraps Llc, Sun Pharm, Teva Parenteral, Xiromed, and Hainan Poly, and is included in twenty-three NDAs. It is available from fifteen suppliers. Additional details are available on the SODIUM NITROPRUSSIDE profile page.
The generic ingredient in SODIUM NITROPRUSSIDE 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.
The generic ingredient in SODIUM NITROPRUSSIDE 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 215846
| Tradename: | SODIUM NITROPRUSSIDE |
| Applicant: | Hainan Poly |
| Ingredient: | sodium nitroprusside |
| Patents: | 0 |
Pharmacology for NDA: 215846
| Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 215846
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM NITROPRUSSIDE | sodium nitroprusside | SOLUTION;INTRAVENOUS | 215846 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-132 | 14335-132-01 | 1 VIAL in 1 CARTON (14335-132-01) / 50 mL in 1 VIAL |
| SODIUM NITROPRUSSIDE | sodium nitroprusside | SOLUTION;INTRAVENOUS | 215846 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-133 | 14335-133-01 | 1 VIAL in 1 CARTON (14335-133-01) / 100 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/50ML (0.2MG/ML) | ||||
| Approval Date: | Aug 26, 2022 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/100ML (0.2MG/ML) | ||||
| Approval Date: | Aug 26, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/100ML (0.5MG/ML) | ||||
| Approval Date: | Aug 26, 2022 | TE: | AP | RLD: | No | ||||
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