Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022201
Company: FERRING
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 |
---|---|---|---|---|---|
02/24/2020 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022201s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022201Orig1s016ltr.pdf | |
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 |
---|---|---|---|---|---|
02/24/2020 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022201s016lbl.pdf | |
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 |