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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 091488


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NDA 091488 describes ATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Eugia Pharma, Hikma, Hospira, Hospira Inc, Meitheal, Mylan Labs Ltd, and Watson Labs Inc, and is included in eleven NDAs. It is available from three 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. Three 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:Meitheal
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 Meitheal Pharmaceuticals Inc. 71288-701 71288-701-05 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-701-05) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-701-06)

Profile for product number 001

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

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