Application Nr Approved Date Route Status External Links
ANDA203339 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Amabelz Is An Estrogen And Progestin Combination Indicated In A Woman With A Uterus For: Amabelz 1 Mg/0.5 Mg And 0.5 Mg/0.1 Mg Are Indicated In A Woman With A Uterus For: • Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause ( 1.1 ) • Prevention Of Postmenopausal Osteoporosis ( 1.3 ) Amabelz 1 Mg/0.5 Mg Is Also Indicated In A Woman With A Uterus For: • Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause ( 1.2 ) 1.1 Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause 1.2 Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause Limitation Of Use When Prescribing Solely For The Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause, Topical Vaginal Products Should Be Considered. 1.3 Prevention Of Postmenopausal Osteoporosis Limitation Of Use Limitation Of Use When Prescribing Solely For The Prevention Of Postmenopausal Osteoporosis, Therapy Should Only Be Considered For Women At Significant Risk Of Osteoporosis And Non-Estrogen Medication Should Be Carefully Considered.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Estradiol ESTRADIOL ZINC3881556
2. Norethindrone

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