Details for New Drug Application (NDA): 216538
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The generic ingredient in CISATRACURIUM BESYLATE is cisatracurium besylate. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
Summary for 216538
Tradename: | CISATRACURIUM BESYLATE |
Applicant: | Hainan Poly |
Ingredient: | cisatracurium besylate |
Patents: | 0 |
Pharmacology for NDA: 216538
Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 216538
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CISATRACURIUM BESYLATE | cisatracurium besylate | INJECTABLE;INJECTION | 216538 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-113 | 70436-113-82 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-113-82) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | Mar 8, 2024 | TE: | AP | RLD: | No |
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