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conjugated estrogens and medroxyprogesterone acetate

FDA Drug Profile — Premphase, Prempro

Drug Details

Generic Name
conjugated estrogens and medroxyprogesterone acetate
Brand Names
Premphase, Prempro
Application Number
NDA020527
Sponsor
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
NDC Codes
5
Dosage Forms
KIT, TABLET, SUGAR COATED
Routes
ORAL
Active Ingredients
ESTROGENS, CONJUGATED, MEDROXYPROGESTERONE ACETATE

Indications and Usage

1 INDICATIONS AND USAGE PREMPRO/PREMPHASE is an estrogen plus progestin indicated in a woman with a uterus for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) • Prevention of Postmenopausal Osteoporosis ( 1.3 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause 1.3 Prevention of Postmenopausal Osteoporosis