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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020898
Company: GENZYME

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THYROGEN THYROTROPIN ALFA 1.1MG/VIAL INJECTABLE;INJECTION 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
11/30/1998 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20898_Thyrogen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20898ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20898_Thyrogen.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/12/2020 SUPPL-65 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020898s063s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020898Orig1s063, s065ltr.pdf
03/12/2020 SUPPL-63 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020898s063s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020898Orig1s063, s065ltr.pdf
04/24/2017 SUPPL-60 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020898s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020898s060ltr.pdf
06/12/2013 SUPPL-56 Supplement

Label is not available on this site.
05/07/2013 SUPPL-55 Supplement

Label is not available on this site.
03/21/2014 SUPPL-54 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020898s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020898Orig1s054ltr.pdf
12/14/2012 SUPPL-53 Supplement

Label is not available on this site.
07/27/2012 SUPPL-51 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020898s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020898Orig1s051ltr.pdf
08/12/2008 SUPPL-38 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020898s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020898s038ltr.pdf
01/24/2006 SUPPL-31 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020898s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020898s031ltr.pdf
12/14/2007 SUPPL-29 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020898s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020898s029ltr.pdf
03/11/2004 SUPPL-21 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20898slr021_Thyrogen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20898slr021ltr.pdf
10/08/2002 SUPPL-14 Supplement

Label is not available on this site.
06/25/2002 SUPPL-13 Supplement

Label is not available on this site.
09/17/2001 SUPPL-12 Supplement

Label is not available on this site.
06/13/2001 SUPPL-11 Supplement

Label is not available on this site.
03/15/2001 SUPPL-10 Supplement

Label is not available on this site.
03/01/2001 SUPPL-9 Supplement

Label is not available on this site.
03/01/2001 SUPPL-8 Supplement

Label is not available on this site.
02/28/2001 SUPPL-7 Supplement

Label is not available on this site.
10/26/2001 SUPPL-5 Supplement

Label is not available on this site.
05/25/2000 SUPPL-4 Supplement

Label is not available on this site.
11/16/1999 SUPPL-3 Supplement

Label is not available on this site.
09/02/1999 SUPPL-2 Supplement

Label is not available on this site.
09/03/1999 SUPPL-1 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/12/2020 SUPPL-65 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020898s063s065lbl.pdf
03/12/2020 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020898s063s065lbl.pdf
04/24/2017 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020898s060lbl.pdf
03/21/2014 SUPPL-54 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020898s054lbl.pdf
07/27/2012 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020898s051lbl.pdf
08/12/2008 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020898s038lbl.pdf
12/14/2007 SUPPL-29 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020898s029lbl.pdf
01/24/2006 SUPPL-31 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020898s031lbl.pdf
03/11/2004 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20898slr021_Thyrogen_lbl.pdf
11/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20898_Thyrogen_prntlbl.pdf
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