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FDA NDA · NDA208564

IMVEXXY

Sponsor: MAYNE PHARMA

APPLICATION
NDA208564
TYPE
NDA
ORIGINAL APPROVAL
2018-05-29
LATEST ACTION
2024-02-15
ROUTE
VAGINAL
DOSAGE FORM
INSERT
MARKETING STATUS
Prescription

Products

IMVEXXY · ReferencePrescription
ESTRADIOL 0.01MG · INSERT · VAGINAL
IMVEXXY · ReferencePrescription
ESTRADIOL 0.004MG · INSERT · VAGINAL

Approval history

2024-02-15Labeling · Supplement 6 · standard — Letter ↗AP
2021-11-16Labeling · Supplement 2 · standard — Letter ↗AP
2019-11-21Labeling · Supplement 3 · standard — Label ↗AP
2018-05-29Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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