Details for New Drug Application (NDA): 091458
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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 091458
Tradename: | ROCURONIUM BROMIDE |
Applicant: | Sagent Pharms Inc |
Ingredient: | rocuronium bromide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091458
Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 091458
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 091458 | ANDA | Sagent Pharmaceuticals | 25021-662 | 25021-662-05 | 10 VIAL in 1 CARTON (25021-662-05) / 5 mL in 1 VIAL |
ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 091458 | ANDA | Sagent Pharmaceuticals | 25021-662 | 25021-662-10 | 10 VIAL in 1 CARTON (25021-662-10) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/5ML (10MG/ML) | ||||
Approval Date: | Jul 28, 2010 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/10ML (10MG/ML) | ||||
Approval Date: | Jul 28, 2010 | TE: | AP | RLD: | No |
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