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FDA NDA · NDA208470

INTRAROSA

Sponsor: MILLICENT

APPLICATION
NDA208470
TYPE
NDA
ORIGINAL APPROVAL
2016-11-16
LATEST ACTION
2018-02-13
ROUTE
VAGINAL
DOSAGE FORM
INSERT
MARKETING STATUS
Prescription

Products

INTRAROSA · ReferencePrescription
PRASTERONE 6.5MG · INSERT · VAGINAL

Approval history

2018-02-13Labeling · Supplement 1 · standard — Label ↗AP
2016-11-16Type 2 New Active Ingredient and Type 4 New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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