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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125422
Company: THROMBOGENICS, INC

Products on BLA 125422

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JETREA	OCRIPLASMIN	2.5MG/ML	INJECTABLE; INTRAVITREAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125422

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2012	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125422s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125422Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125422_jetrea_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2017	SUPPL-38	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125422s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125422Orig1s038ltr.pdf
03/27/2016	SUPPL-37	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125422s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125422Orig1s037ltr.pdf
06/13/2014	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125422s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125422Orig1s025ltr.pdf

Labels for BLA 125422

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2017	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125422s038lbl.pdf
03/27/2016	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125422s037lbl.pdf
06/13/2014	SUPPL-25	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125422s025lbl.pdf
10/17/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125422s000lbl.pdf

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