Details for New Drug Application (NDA): 091115
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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 091115
Tradename: | ROCURONIUM BROMIDE |
Applicant: | Tamarang |
Ingredient: | rocuronium bromide |
Patents: | 0 |
Pharmacology for NDA: 091115
Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 091115
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 091115 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-4200 | 39822-4200-2 | 10 VIAL in 1 CARTON (39822-4200-2) / 5 mL in 1 VIAL (39822-4200-1) |
ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 091115 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-4200 | 39822-4200-6 | 10 VIAL in 1 CARTON (39822-4200-6) / 10 mL in 1 VIAL (39822-4200-5) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/5ML (10MG/ML) | ||||
Approval Date: | Aug 27, 2012 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/10ML (10MG/ML) | ||||
Approval Date: | Aug 27, 2012 | TE: | AP | RLD: | No |
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