Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065004
Company: HIKMA

Products on ANDA 065004

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOSPORINE	CYCLOSPORINE	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065004

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65004LTR.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/23/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/03/2001	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/30/2002	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065004

CYCLOSPORINE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOSPORINE	CYCLOSPORINE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	065004	HIKMA
CYCLOSPORINE	CYCLOSPORINE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	065151	PADAGIS US
SANDIMMUNE	CYCLOSPORINE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	050573	NOVARTIS