FDA NDA · NDA022057

PROGESTERONE

Sponsor: FERRING

APPLICATION

NDA022057

TYPE

NDA

ORIGINAL APPROVAL

2007-06-21

LATEST ACTION

2026-07-15

ROUTE

VAGINAL

DOSAGE FORM

INSERT

MARKETING STATUS

Prescription

Products

ENDOMETRIN · ReferencePrescription

PROGESTERONE 100MG · INSERT · VAGINAL

2026-07-15Labeling · Supplement 12 · standard — Letter ↗AP

2016-06-16Manufacturing (CMC) · Supplement 10 · standardAP

2016-05-10Manufacturing (CMC) · Supplement 9 · standardAP

2016-04-07Manufacturing (CMC) · Supplement 8 · standardAP

2014-04-21Manufacturing (CMC) · Supplement 7 · standardAP

2013-06-11Manufacturing (CMC) · Supplement 6 · standardAP

2013-04-08Manufacturing (CMC) · Supplement 5 · standardAP

2009-06-03Labeling · Supplement 2 · standard — Letter ↗AP

2008-02-26Labeling · Supplement 1 · standard — Letter ↗AP

2007-06-21Type 3 - New Dosage Form · Original · standard — Label ↗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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