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Generated: November 17, 2018

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Details for New Drug Application (NDA): 090782

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NDA 090782 describes ATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Aurobindo Pharma Ltd, Baxter Hlthcare, Baxter Hlthcare Corp, Hospira, Hospira Inc, Mylan Labs Ltd, Nanjing King-friend, Watson Labs Inc, and West-ward Pharms Int, and is included in eleven NDAs. It is available from six suppliers. Additional details are available on the ATRACURIUM BESYLATE PRESERVATIVE FREE profile page.

The generic ingredient in ATRACURIUM BESYLATE PRESERVATIVE FREE is atracurium besylate. There are sixteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the atracurium besylate profile page.
Summary for 090782
Tradename:ATRACURIUM BESYLATE PRESERVATIVE FREE
Applicant:Hospira Inc
Ingredient:atracurium besylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090782
Medical Subject Heading (MeSH) Categories for 090782
Suppliers and Packaging for NDA: 090782
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATRACURIUM BESYLATE PRESERVATIVE FREE atracurium besylate INJECTABLE;INJECTION 090782 ANDA Hospira, Inc. 0409-1109 0409-1109-01 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1109-01) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-1109-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Oct 18, 2012TE:APRLD:No

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