Application Nr Approved Date Route Status External Links
NDA021355 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Angeliq 0.25 Mg Drospirenone (Drsp)/0.5 Mg Estradiol (E2) Is An Estrogen/progestin Indicated In Women With An Intact Uterus For The Treatment Of: • Vasomotor Symptoms Due To Menopause. ( 1.1 ) Angeliq 0.5 Mg Drsp/1 Mg E2 Is An Estrogen/progestin Indicated In Women With An Intact Uterus For The Treatment Of: • Vasomotor Symptoms Due To Menopause. ( 1.1 ) • Vulvar And Vaginal Atrophy Symptoms Due To Menopause. ( 1.2 ) 1.1 Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause • Angeliq 0.25 Mg Drospirenone (Drsp)/0.5 Mg Estradiol (E2) Is Indicated For The Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause In Women Who Have A Uterus. • Angeliq 0.5 Mg Drsp/1 Mg E2 Is Indicated For The Treatment Of Moderate To Severe Vasomotor Symptoms Associated Due To Menopause In Women Who Have A Uterus. 1.2 Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause • Angeliq 0.5 Mg Drsp/1 Mg E2 Is Indicated For The Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause In Women Who Have A Uterus.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Drospirenone DROSPIRENONE ZINC3927200
2. Estradiol ESTRADIOL ZINC3881556

Comments