Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065017
Company: SANDOZ

Products on ANDA 065017

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	AB1	No	No
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065017

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/13/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65017a_Cyclosporine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65017a_Cyclosporine.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/04/2016	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
07/08/2013	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
12/11/2012	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
01/27/2012	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/06/2007	SUPPL-11	Labeling		Label is not available on this site.
04/19/2003	SUPPL-8	Labeling		Label is not available on this site.
04/19/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/07/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
12/06/2001	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/06/2001	SUPPL-4	Labeling		Label is not available on this site.
05/11/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
05/11/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
05/11/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 065017

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65017a_Cyclosporine_prntlbl.pdf

Therapeutic Equivalents for ANDA 065017

CYCLOSPORINE

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	210721	APOTEX
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	065044	DR REDDYS LABS SA
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	065110	IVAX SUB TEVA PHARMS
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	216046	ONESOURCE SPECIALTY
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	219049	QILU
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

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	210721	APOTEX
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	065044	DR REDDYS LABS SA
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	065110	IVAX SUB TEVA PHARMS
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	216046	ONESOURCE SPECIALTY
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	219049	QILU
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