Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 101063
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELSPAR ASPARAGINASE 10,000IU/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
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
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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