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Biologic License Application (BLA): 103608
Company: CYTOGEN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROSTASCINT CAPROMAB PENDETIDE 05.MG/ML VIAL; INTRAVENOUS Prescription None 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
10/28/1996 ORIG-1 Approval N/A Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/capcyt102896lab.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/capcyt102896L.htm https://web.archive.org/web/20170118085129/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080734.htm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2012 SUPPL-5043 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103608s5043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103608s5043ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/26/2012 SUPPL-5043 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103608s5043lbl.pdf
10/28/1996 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/capcyt102896lab.pdf
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