Details for New Drug Application (NDA): 078519
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NDA 078519 describes ROCURONIUM BROMIDE, which is a drug marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Institutional, Norvium Bioscience, Piramal Critical, Prinston Inc, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Tamarang, Teva Pharms, and West Ward Pharm Corp, and is included in eighteen NDAs. It is available from twenty-two suppliers. Additional details are available on the ROCURONIUM BROMIDE profile page.
The generic ingredient in ROCURONIUM BROMIDE is rocuronium bromide. There are eleven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.
The generic ingredient in ROCURONIUM BROMIDE is rocuronium bromide. There are eleven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.
Summary for 078519
| Tradename: | ROCURONIUM BROMIDE |
| Applicant: | Hospira |
| Ingredient: | rocuronium bromide |
| Patents: | 0 |
Pharmacology for NDA: 078519
| Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 078519
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 078519 | ANDA | Hospira, Inc. | 0409-9558 | 0409-9558-49 | 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-49) / 5 mL in 1 VIAL, MULTI-DOSE (0409-9558-69) |
| ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 078519 | ANDA | Hospira, Inc. | 0409-9558 | 0409-9558-50 | 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-50) / 10 mL in 1 VIAL, MULTI-DOSE (0409-9558-70) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | Nov 26, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/10ML (10MG/ML) | ||||
| Approval Date: | Nov 26, 2008 | TE: | AP | RLD: | No | ||||
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