Drugs@FDA: FDA-Approved Drugs
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.cfm |
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. |
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06/25/2002 | SUPPL-13 | Supplement |
Label is not available on this site. |
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09/17/2001 | SUPPL-12 | Supplement |
Label is not available on this site. |
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06/13/2001 | SUPPL-11 | Supplement |
Label is not available on this site. |
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03/15/2001 | SUPPL-10 | Supplement |
Label is not available on this site. |
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03/01/2001 | SUPPL-9 | Supplement |
Label is not available on this site. |
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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. |
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10/26/2001 | SUPPL-5 | Supplement |
Label is not available on this site. |
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05/25/2000 | SUPPL-4 | Supplement |
Label is not available on this site. |
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11/16/1999 | SUPPL-3 | Supplement |
Label is not available on this site. |
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09/02/1999 | SUPPL-2 | Supplement |
Label is not available on this site. |
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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 |