Details for New Drug Application (NDA): 200159
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The generic ingredient in CISATRACURIUM BESYLATE is cisatracurium besylate. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
Summary for 200159
Tradename: | CISATRACURIUM BESYLATE |
Applicant: | Sandoz Inc |
Ingredient: | cisatracurium besylate |
Patents: | 0 |
Pharmacology for NDA: 200159
Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 200159
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CISATRACURIUM BESYLATE | cisatracurium besylate | INJECTABLE;INJECTION | 200159 | ANDA | Sandoz Inc | 0781-3152 | 0781-3152-95 | 10 VIAL, MULTI-DOSE in 1 CARTON (0781-3152-95) / 10 mL in 1 VIAL, MULTI-DOSE (0781-3152-70) |
CISATRACURIUM BESYLATE | cisatracurium besylate | INJECTABLE;INJECTION | 200159 | ANDA | Civica, Inc. | 72572-066 | 72572-066-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (72572-066-10) / 10 mL in 1 VIAL, MULTI-DOSE (72572-066-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | Feb 3, 2012 | TE: | AP | RLD: | No |
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