Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103786
Company: EKR THERAP

Products on BLA 103786

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETAVASE	RETEPLASE	18.8MG/VIAL	VIAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103786

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