Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065078
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOSPORINE CYCLOSPORINE 100MG/ML SOLUTION;ORAL Prescription AB1 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/25/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

09/24/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/11/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/26/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/12/2007 SUPPL-1 Labeling

Label is not available on this site.

CYCLOSPORINE

SOLUTION;ORAL; 100MG/ML
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOSPORINE CYCLOSPORINE 100MG/ML SOLUTION;ORAL Prescription No AB1 065025 ABBVIE
CYCLOSPORINE CYCLOSPORINE 100MG/ML SOLUTION;ORAL Prescription No AB1 065078 IVAX SUB TEVA PHARMS
CYCLOSPORINE CYCLOSPORINE 100MG/ML SOLUTION;ORAL Prescription No AB1 065054 MAYNE PHARMA
NEORAL CYCLOSPORINE 100MG/ML SOLUTION;ORAL Prescription Yes AB1 050716 NOVARTIS

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