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TX-001HR Approval Status

FDA Approved: No (Pending Approval)
Brand name: TX-001HR
Generic name: estradiol and progesterone
Company: TherapeuticsMD, Inc.
Treatment for: Perimenopausal Symptoms

TX-001HR is an investigational bio-identical hormone combination of estradiol and progesterone in development for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

Development Status and FDA Approval Process for TX-001HR

DateArticle
Mar  8, 2018TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for TX-001HR
Dec 28, 2017TherapeuticsMD Announces Submission of New Drug Application for TX-001HR

Further information

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