Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065004
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOSPORINE CYCLOSPORINE 50MG/ML INJECTABLE;INJECTION Prescription AP No No
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.

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 065151 AM REGENT
CYCLOSPORINE CYCLOSPORINE 50MG/ML INJECTABLE;INJECTION Prescription No AP 065004 WEST-WARD PHARMS INT
SANDIMMUNE CYCLOSPORINE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 050573 NOVARTIS

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