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INTRAROSA

NDA · New Drug Application · Sponsor: MILLICENT · Approved 2016-11-16

Drug application

FDA Application #

NDA208470

Application type

New Drug Application

Brand name

INTRAROSA

Generic name

PRASTERONE

Active ingredients

PRASTERONE

Dosage form

INSERT

Route

VAGINAL

Marketing status

Prescription

Sponsor

MILLICENT

Manufacturer

Millicent US, Inc.

First approval

2016-11-16

Source

Authoritative

Drugs@FDA application overview

Machine

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