Methyltestosterone

FDA Drug Profile — Methyltestosterone

Drug Details

Generic Name
Methyltestosterone
Brand Names
Methyltestosterone
Application Number
ANDA215270
Sponsor
Symbiotec Pharmalab Limited
NDC Codes
5
Dosage Forms
POWDER, CAPSULE
Routes
ORAL
Active Ingredients
METHYLTESTOSTERONE

Indications and Usage

5- Indication ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS.