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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 101063
Company: MERCK

Products on BLA 101063

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELSPAR	ASPARAGINASE	10,000IU/VIAL	VIAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 101063

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/10/1978	ORIG-1	Approval		N/A		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2013	SUPPL-5169	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/101063s5169lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/101063Orig1s5169ltr.pdf
05/20/2010	SUPPL-5121	Supplement		Label is not available on this site.
03/30/2007	SUPPL-5081	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/101063s5081LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/101063s5081LTR.pdf
07/21/2006	SUPPL-5071	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/101063s5071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/101063 5071 Ltr.pdf
06/29/2004	SUPPL-5036	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/101063_5036ltr.pdf
08/01/2002	SUPPL-5012	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/aspamer080102LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/aspamer080102L.pdf

Labels for BLA 101063

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2013	SUPPL-5169	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/101063s5169lbl.pdf
03/30/2007	SUPPL-5081	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/101063s5081LBL.pdf
07/21/2006	SUPPL-5071	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/101063s5071lbl.pdf
08/01/2002	SUPPL-5012	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/aspamer080102LB.pdf

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