FDA Approved: DOTTI — Original Application (Amneal Pharmaceuticals LLC)

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Summary

The FDA approved Amneal's original application for DOTTI, a generic estradiol product, expanding availability of estrogen replacement therapy. This ANDA approva…

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Diseases / indications

• Menopause
• Postmenopausal Osteoporosis
• Vasomotor Symptoms of Menopause
• Vulvar and Vaginal Atrophy

Drugs mentioned

• DOTTI (Estradiol)

Snippet

ORIG AP for DOTTI (ESTRADIOL)