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Last Updated: December 14, 2019

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Details for New Drug Application (NDA): 091488

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NDA 091488 describes ATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Aurobindo Pharma Ltd, Baxter Hlthcare, Baxter Hlthcare Corp, Hong Kong, Hospira, Hospira Inc, Mylan Labs Ltd, Watson Labs Inc, and West-ward Pharms Int, and is included in eleven NDAs. It is available from four 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. Four suppliers are listed for this compound. Additional details are available on the atracurium besylate profile page.
Summary for 091488
Tradename:ATRACURIUM BESYLATE PRESERVATIVE FREE
Applicant:Hong Kong
Ingredient:atracurium besylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091488
Medical Subject Heading (MeSH) Categories for 091488
Suppliers and Packaging for NDA: 091488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATRACURIUM BESYLATE PRESERVATIVE FREE atracurium besylate INJECTABLE;INJECTION 091488 ANDA Sagent Pharmaceuticals 25021-659 25021-659-68 10 VIAL in 1 CARTON (25021-659-68) > 5 mL in 1 VIAL
ATRACURIUM BESYLATE PRESERVATIVE FREE atracurium besylate INJECTABLE;INJECTION 091488 ANDA Sagent Pharmaceuticals 25021-659 25021-659-05 10 VIAL in 1 CARTON (25021-659-05) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Feb 17, 2012TE:APRLD:No

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