Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020807
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REFLUDAN LEPIRUDIN RECOMBINANT 50MG/VIAL INJECTABLE;INJECTION Discontinued 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
03/06/1998 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20807_Refludan_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20807_Refludan.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2007 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020807s015ltr.pdf
11/07/2006 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020807s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020807s011ltr.pdf
04/02/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20807slr005ltr.pdf
04/01/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-2 Labeling

Label is not available on this site.

11/17/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/07/2006 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020807s011lbl.pdf

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