Details for New Drug Application (NDA): 210855
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NDA 210855 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, Micro Labs, Mylan Labs Ltd, Nexus, Norvium Bioscience, Sagent Pharms Inc, Slate Run Pharma, Somerset Theraps Llc, Sun Pharm, Teva Parenteral, and Xiromed, 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 210855
| Tradename: | SODIUM NITROPRUSSIDE |
| Applicant: | Cipla |
| Ingredient: | sodium nitroprusside |
| Patents: | 0 |
Pharmacology for NDA: 210855
| Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 210855
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM NITROPRUSSIDE | sodium nitroprusside | INJECTABLE;INJECTION | 210855 | ANDA | Cipla USA Inc. | 69097-532 | 69097-532-32 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-532-32) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/ML | ||||
| Approval Date: | Jul 16, 2018 | TE: | RLD: | No | |||||
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