Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065025
Company: ABBVIE

Products on ANDA 065025

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 065025

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.

Therapeutic Equivalents for ANDA 065025

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