Details for New Drug Application (NDA): 078651
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NDA 078651 describes ROCURONIUM BROMIDE, which is a drug marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Institutional, Piramal Critical, Prinston Inc, Rising, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Tamarang, Teva Pharms, West Ward Pharm Corp, and Sterinova Inc, and is included in twenty-one NDAs. It is available from twenty-four suppliers. There is one patent protecting this drug. 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-four 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-four 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 |
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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