Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065025
Company: ABBVIE
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
03/03/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65025_Cyclosporine.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

10/06/2015 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

10/06/2015 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

02/06/2013 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

04/27/2010 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

12/09/2009 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/09/2009 SUPPL-13 Labeling

Label is not available on this site.

07/13/2007 SUPPL-12 Labeling

Label is not available on this site.

02/26/2007 SUPPL-11 Labeling

Label is not available on this site.

02/07/2007 SUPPL-10 Labeling

Label is not available on this site.

09/01/2005 SUPPL-7 Labeling

Label is not available on this site.

10/05/2005 SUPPL-6 Labeling

Label is not available on this site.

04/26/2004 SUPPL-5 Labeling

Label is not available on this site.

12/14/2001 SUPPL-4 Labeling

Label is not available on this site.

08/15/2001 SUPPL-3 Bioequivalence

Label is not available on this site.

08/09/2000 SUPPL-2 Labeling

Label is not available on this site.

09/05/2000 SUPPL-1 Manufacturing (CMC)-Control

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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