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FDA NDA · NDA020843

PROMETRIUM

Sponsor: VIRTUS PHARMS

APPLICATION
NDA020843
TYPE
NDA
ORIGINAL APPROVAL
1998-12-16
LATEST ACTION
2014-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

PROMETRIUMPrescription
PROGESTERONE 200MG · CAPSULE · ORAL
PROMETRIUMPrescription
PROGESTERONE 300MG · CAPSULE · ORAL
PROMETRIUMPrescription
PROGESTERONE 100MG · CAPSULE · ORAL

Approval history

2014-09-30Manufacturing (CMC) · Supplement 14 · standardAP
2011-11-01Labeling · Supplement 11 · unknown — Letter ↗AP
2009-06-30Labeling · Supplement 10 · standard — Letter ↗AP
2004-12-10Labeling · Supplement 5 · standard — Label ↗AP
2004-12-10Labeling · Supplement 6 · standard — Label ↗AP
2004-03-04Labeling · Supplement 8 · standard — Letter ↗AP
2002-06-27Manufacturing (CMC) · Supplement 7 · standardAP
2000-04-17Manufacturing (CMC) · Supplement 3 · standardAP
2000-04-17Manufacturing (CMC) · Supplement 4 · standardAP
2000-04-17Manufacturing (CMC) · Supplement 2 · standardAP
1999-10-15Manufacturing (CMC) · Supplement 1 · standardAP
1998-12-16Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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