conjugated estrogens and medroxyprogesterone acetate

FDA Drug Profile — Prempro, Premphase

conjugated estrogens and medroxyprogesterone acetate is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including Prempro, Premphase. Available dosage forms: tablet, sugar coated, kit.

Drug Details

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