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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 206791


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NDA 206791 describes CISATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hengrui Pharma, Sandoz Inc, and Somerset Theraps Llc, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the CISATRACURIUM BESYLATE PRESERVATIVE FREE profile page.

The generic ingredient in CISATRACURIUM BESYLATE PRESERVATIVE FREE 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 206791
Pharmacology for NDA: 206791
Suppliers and Packaging for NDA: 206791
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 206791 ANDA Somerset Therapeutics, LLC 70069-141 70069-141-01 1 VIAL in 1 CARTON (70069-141-01) / 5 mL in 1 VIAL
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 206791 ANDA Somerset Therapeutics, LLC 70069-141 70069-141-10 10 VIAL in 1 CARTON (70069-141-10) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Feb 20, 2019TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Feb 20, 2019TE:APRLD:No

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