Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065040
Company: APOTEX

Products on ANDA 065040

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	AB2	No	No
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065040

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2002	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65040ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065040.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2014	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/26/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/27/2006	SUPPL-5	Labeling		Label is not available on this site.
05/08/2006	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065040

CYCLOSPORINE

CAPSULE;ORAL; 25MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB2	065040	APOTEX
SANDIMMUNE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	Yes	AB2	050625	NOVARTIS

CAPSULE;ORAL; 100MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB2	065040	APOTEX
SANDIMMUNE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	Yes	AB2	050625	NOVARTIS