Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065151
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOSPORINE CYCLOSPORINE 50MG/ML INJECTABLE;INJECTION Prescription AP 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
10/07/2003 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
06/30/2015 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/31/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/10/2006 SUPPL-4 Labeling

Label is not available on this site.

06/24/2005 SUPPL-3 Labeling

Label is not available on this site.

CYCLOSPORINE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOSPORINE CYCLOSPORINE 50MG/ML INJECTABLE;INJECTION Prescription No AP 065151 AM REGENT
CYCLOSPORINE CYCLOSPORINE 50MG/ML INJECTABLE;INJECTION Prescription No AP 065004 WEST-WARD PHARMS INT
SANDIMMUNE CYCLOSPORINE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 050573 NOVARTIS

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