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Generated: January 23, 2019

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Details for New Drug Application (NDA): 065078

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NDA 065078 describes CYCLOSPORINE, which is a drug marketed by Apotex, Ivax Sub Teva Pharms, Mayne Pharma, Sandoz, Luitpold, West-ward Pharms Int, Abbvie, Apotex Inc, and Wockhardt Bio Ag, and is included in eleven NDAs. It is available from seven suppliers. Additional details are available on the CYCLOSPORINE profile page.

The generic ingredient in CYCLOSPORINE is cyclosporine. There are eighteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 065078
Applicant:Ivax Sub Teva Pharms
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 065078
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOSPORINE cyclosporine SOLUTION;ORAL 065078 ANDA Teva Pharmaceuticals USA, Inc. 0172-7313 0172-7313-20 1 BOTTLE in 1 PACKAGE (0172-7313-20) > 50 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Mar 25, 2005TE:AB1RLD:No

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