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 |
| 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 |