Details for New Drug Application (NDA): 078651
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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 078651
Tradename: | ROCURONIUM BROMIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | rocuronium bromide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078651
Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 078651
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 078651 | ANDA | Fresenius Kabi USA, LLC | 63323-426 | 63323-426-15 | 10 VIAL in 1 TRAY (63323-426-15) / 5 mL in 1 VIAL (63323-426-12) |
ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 078651 | ANDA | Fresenius Kabi USA, LLC | 63323-426 | 63323-426-05 | 10 VIAL in 1 TRAY (63323-426-05) / 5 mL in 1 VIAL (63323-426-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/5ML (10MG/ML) | ||||
Approval Date: | Dec 29, 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: | Dec 29, 2008 | TE: | AP | RLD: | No |
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