Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022201
Company: FERRING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FIRMAGON DEGARELIX ACETATE EQ 80MG BASE/VIAL POWDER;SUBCUTANEOUS Prescription None Yes No
FIRMAGON DEGARELIX ACETATE EQ 120MG BASE/VIAL POWDER;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
12/24/2008 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022201lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022201s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022201s000_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022201s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/21/2016 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/12/2016 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/27/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022201Orig1s011ltr.pdf
07/31/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/26/2015 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022201Orig1s009ltr.pdf
12/15/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/10/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/26/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/25/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/16/2013 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022201Orig1s003ltr.pdf
03/05/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022201Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/27/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s011lbl.pdf
02/26/2015 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s009lbl.pdf
08/16/2013 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s003lbl.pdf
03/05/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s002lbl.pdf
12/24/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022201lbl.pdf

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