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, Micro Labs, Mylan Labs Ltd, Nexus, Pharmobedient, Sagent Pharms Inc, Somerset Theraps Llc, Sun Pharm, Teva Parenteral, and Xiromed, and is included in twenty-three NDAs. It is available from twelve suppliers. Additional details are available on the SODIUM NITROPRUSSIDE profile page.
The generic ingredient in SODIUM NITROPRUSSIDE 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.
The generic ingredient in SODIUM NITROPRUSSIDE 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 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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