Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065003
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENGRAF CYCLOSPORINE 25MG CAPSULE;ORAL Prescription AB1 No No
GENGRAF CYCLOSPORINE 50MG CAPSULE;ORAL Discontinued None No No
GENGRAF CYCLOSPORINE 100MG CAPSULE;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
05/12/2000 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/065003_gengraf_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/30/2015 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

02/06/2013 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

05/05/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/09/2009 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-10 Labeling

Label is not available on this site.

07/13/2007 SUPPL-9 Labeling

Label is not available on this site.

02/26/2007 SUPPL-8 Labeling

Label is not available on this site.

02/07/2007 SUPPL-7 Labeling

Label is not available on this site.

09/01/2005 SUPPL-6 Labeling

Label is not available on this site.

09/01/2005 SUPPL-5 Labeling

Label is not available on this site.

05/14/2004 SUPPL-2 Labeling

Label is not available on this site.

12/14/2001 SUPPL-1 Labeling

Label is not available on this site.

GENGRAF

CAPSULE;ORAL; 25MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065110 IVAX SUB TEVA PHARMS
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065044 MAYNE PHARMA
CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065017 SANDOZ
GENGRAF CYCLOSPORINE 25MG CAPSULE;ORAL Prescription No AB1 065003 ABBVIE
NEORAL CYCLOSPORINE 25MG CAPSULE;ORAL Prescription Yes AB1 050715 NOVARTIS

CAPSULE;ORAL; 100MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065110 IVAX SUB TEVA PHARMS
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065044 MAYNE PHARMA
CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065017 SANDOZ
GENGRAF CYCLOSPORINE 100MG CAPSULE;ORAL Prescription No AB1 065003 ABBVIE
NEORAL CYCLOSPORINE 100MG CAPSULE;ORAL Prescription Yes AB1 050715 NOVARTIS

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