Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065078
Company: IVAX SUB TEVA PHARMS

Products on ANDA 065078

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOSPORINE	CYCLOSPORINE	100MG/ML	SOLUTION;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065078

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.

Therapeutic Equivalents for ANDA 065078

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
NEORAL	CYCLOSPORINE	100MG/ML	SOLUTION;ORAL	Prescription	Yes	AB1	050716	NOVARTIS