medroxyprogesterone acetate

FDA Drug Profile — medroxyprogesterone acetate, Depo-Provera, Medroxyprogesterone Acetate Injectable Suspension, Depo-SubQ Provera, Provera

medroxyprogesterone acetate is listed in the FDA National Drug Code directory with 20 NDC codes, marketed under brand names including medroxyprogesterone acetate, Depo-Provera, Medroxyprogesterone Acetate Injectable Suspension. Available dosage forms: injection, suspension, powder, tablet.

Drug Details

Generic Name
medroxyprogesterone acetate
Brand Names
medroxyprogesterone acetate, Depo-Provera, Medroxyprogesterone Acetate Injectable Suspension, Depo-SubQ Provera, Provera
Application Number
NDA020246
Sponsor
Prasco Laboratories
NDC Codes
20
Dosage Forms
INJECTION, SUSPENSION, POWDER, TABLET
Routes
INTRAMUSCULAR, ORAL, SUBCUTANEOUS
Active Ingredients
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