Details for New Drug Application (NDA): 213453
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The generic ingredient in ROCURONIUM BROMIDE is rocuronium bromide. There are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.
Summary for 213453
Tradename: | ROCURONIUM BROMIDE |
Applicant: | Meitheal |
Ingredient: | rocuronium bromide |
Patents: | 0 |
Pharmacology for NDA: 213453
Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 213453
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 213453 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-700 | 71288-700-06 | 10 VIAL, MULTI-DOSE in 1 CARTON (71288-700-06) / 5 mL in 1 VIAL, MULTI-DOSE (71288-700-05) |
ROCURONIUM BROMIDE | rocuronium bromide | INJECTABLE;INJECTION | 213453 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-718 | 71288-718-11 | 10 VIAL, MULTI-DOSE in 1 CARTON (71288-718-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-718-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/5ML (10MG/ML) | ||||
Approval Date: | May 8, 2023 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/10ML (10MG/ML) | ||||
Approval Date: | May 8, 2023 | TE: | AP | RLD: | No |
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