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Details for New Drug Application (NDA): 206011

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NDA 206011 describes ATRACURIUM BESYLATE, which is a drug marketed by West-ward Pharms Int, Aurobindo Pharma Ltd, Baxter Hlthcare, Hospira, Watson Labs Inc, Baxter Hlthcare Corp, Hospira Inc, Teva Parenteral, and Nanjing King-friend, and is included in twenty NDAs. It is available from four suppliers. Additional details are available on the ATRACURIUM BESYLATE profile page.

The generic ingredient in ATRACURIUM BESYLATE is atracurium besylate. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the atracurium besylate profile page.

Summary for NDA: 206011

Tradename:
ATRACURIUM BESYLATE
Applicant:
Aurobindo Pharma Ltd
Ingredient:
atracurium besylate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 206011

Suppliers and Packaging for NDA: 206011

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATRACURIUM BESYLATE
atracurium besylate
INJECTABLE;INJECTION 206011 ANDA AuroMedics Pharma LLC 55150-217 55150-217-10 10 VIAL, MULTI-DOSE in 1 CARTON (55150-217-10) > 10 mL in 1 VIAL, MULTI-DOSE
ATRACURIUM BESYLATE
atracurium besylate
INJECTABLE;INJECTION 206011 ANDA Aurobindo Pharma Limited 65862-985 65862-985-10 10 VIAL, MULTI-DOSE in 1 CARTON (65862-985-10) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Apr 8, 2015TE:APRLD:No


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