An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065003
Company: ABBVIE

Products on ANDA 065003

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065003

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.

Therapeutic Equivalents for ANDA 065003

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	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	065017	SANDOZ
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	216046	STRIDES PHARMA
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	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	065017	SANDOZ
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	216046	STRIDES PHARMA
GENGRAF	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	065003	ABBVIE
NEORAL	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	Yes	AB1	050715	NOVARTIS

Top