Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 Yes Yes
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 Type 1 - New Molecular Entity PRIORITY; 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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/24/2017 SUPPL-60 Labeling-Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

05/07/2013 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

03/21/2014 SUPPL-54 Efficacy-New Indication 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 Manufacturing (CMC)

Label is not available on this site.

07/27/2012 SUPPL-51 Labeling-Package Insert 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 Labeling 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 Efficacy-Labeling Change With Clinical Data 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 Efficacy-New Indication 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 Labeling 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 Manufacturing (CMC)

Label is not available on this site.

06/25/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/13/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/2001 SUPPL-5 Labeling

Label is not available on this site.

05/25/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/02/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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