An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022201
Company: FERRING

Summary Review

Products on NDA 022201

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022201

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

Labels for NDA 022201

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

Top