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. Fourteen 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) |
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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