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FDA-approved product context

Estradiol + progesterone

A fixed oral combination for moderate-to-severe menopausal vasomotor symptoms in women with a uterus.

Regulatory status and key limits

FDA-approved product context

A fixed oral combination for moderate-to-severe menopausal vasomotor symptoms in women with a uterus.

Reviewed October 10, 2026. Product and route distinctions stay attached to the source; this is not a treatment recommendation.

Source checked October 10, 2026 · Editorial source review · Not medical advice
No dosing or purchase guidance. This information is not a recommendation to use a compound.

Evidence and source limits

The February 2026 label describes an estrogen-plus-progesterone capsule combination with a defined menopausal vasomotor-symptom indication. It records an initial U.S. approval and product-specific labeling changes.

Warnings and contraindications remain despite changes to the boxed warning. Thromboembolic disease, malignancy, liver disease and individual risk factors still require assessment. This is not approval of every custom hormone mixture.

Approval applies to the specific labeled product, route and indication, not every preparation of this ingredient or a wellness mixture. Read the original full label and discuss individual circumstances with a medical professional. No dosing or preparation instructions are included.

Original source

Original source: Estradiol + progesterone ↗

Interpretation is limited to the source linked above. Educational source review, not independent medical review. No dosing, preparation instructions, seller links or treatment endorsement.