Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021318
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FORTEO TERIPARATIDE RECOMBINANT HUMAN 0.75MG/3ML (0.25MG/ML) INJECTABLE;SUBCUTANEOUS Discontinued None No No
FORTEO TERIPARATIDE RECOMBINANT HUMAN 0.6MG/2.4ML (0.25MG/ML) INJECTABLE;SUBCUTANEOUS 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
11/26/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21318.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-318_Forteo.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/03/2019 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021318s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021318Orig1s052ltr.pdf
04/28/2017 SUPPL-51 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021318Orig1s051ltr.pdf
11/23/2015 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

09/12/2014 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

08/13/2014 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

04/11/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/05/2014 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/30/2013 SUPPL-36 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021318s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021318Orig1s036ltr.pdf
08/02/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/13/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/13/2012 SUPPL-27 Labeling-Medication Guide Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021318s027ltr.pdf
08/10/2011 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021318s026ltr.pdf
06/25/2008 SUPPL-16 Labeling-Package Insert Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021318Orig1s016.pdf
02/28/2008 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021318s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s015ltr.pdf
07/22/2009 SUPPL-12 Efficacy-New Indication, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021318s012ltr.pdf
05/19/2007 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021318s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021318s009ltr.pdf
09/03/2004 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318s004ltr.pdf
06/02/2004 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318slr002_forteo_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318slr002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/03/2019 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021318s052lbl.pdf
08/30/2013 SUPPL-36 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021318s036lbl.pdf
07/22/2009 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf
07/22/2009 SUPPL-12 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf
02/28/2008 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021318s015lbl.pdf
05/19/2007 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021318s009lbl.pdf
09/03/2004 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318s004lbl.pdf
06/02/2004 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318slr002_forteo_lbl.pdf
11/26/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf

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