FDA NDA · NDA022201

FIRMAGON

degarelix

Sponsor: FERRING

APPLICATION

NDA022201

TYPE

NDA

ORIGINAL APPROVAL

2008-12-24

LATEST ACTION

2020-02-24

ROUTE

SUBCUTANEOUS

DOSAGE FORM

POWDER

MARKETING STATUS

Prescription

Products

FIRMAGON · ReferencePrescription

DEGARELIX ACETATE EQ 120MG BASE/VIAL · POWDER · SUBCUTANEOUS

FIRMAGON · ReferencePrescription

DEGARELIX ACETATE EQ 80MG BASE/VIAL · POWDER · SUBCUTANEOUS

2020-02-24Labeling · Supplement 16 · standard — Label ↗AP

2016-06-21Manufacturing (CMC) · Supplement 13 · standardAP

2016-01-12Manufacturing (CMC) · Supplement 12 · standardAP

2015-10-27Labeling · Supplement 11 · standard — Label ↗AP

2015-07-31Manufacturing (CMC) · Supplement 10 · standardAP

2015-02-26Labeling · Supplement 9 · standard — Letter ↗AP

2014-12-15Manufacturing (CMC) · Supplement 8 · standardAP

2014-11-10Manufacturing (CMC) · Supplement 6 · standardAP

2014-09-26Manufacturing (CMC) · Supplement 5 · standardAP

2014-03-25Manufacturing (CMC) · Supplement 4 · standardAP

2013-08-16Labeling · Supplement 3 · standard — Label ↗AP

2013-03-05Labeling · Supplement 2 · standard — Label ↗AP

2008-12-24Type 1 - New Molecular Entity · Original · standard — Review ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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