Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103786
Company: EKR THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETAVASE RETEPLASE 18.8MG/VIAL VIAL 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
05/06/1998 ORIG-1 Approval N/A Letter
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/retboe103096L.htm https://web.archive.org/web/20130523120940/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093343.htm

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