osphena ospemifene tablet film coated
1 INDICATIONS AND USAGE OSPHENA is indicated for: OSPHENA is an estrogen agonist/antagonist indicated for: The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1.1 ) The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1.2 ) 1.1 The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause. 1.2 The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause.
shionogi inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied OSPHENA tablets are white to off-white, oval, biconvex, film coated tablets containing 60 mg of
OSPEMIFENE and engraved with "60" on one side. They are available as follows: NDC 59630-580-90 Bottle of 90 tablets 16.2 Storage and Handling Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
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