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ORA-TESTRYL (NDA011359)- (2MG,5MG)

FLUOXYMESTERONE BRISTOL MYERS SQUIBB
2MG,5MG
No No
Expired Expired
None None
None No
In the male—ORA-TESTRYL Tablets are indicated for Replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) testicular failure due to cryptorchidism, bilateral torsion, orchitis , vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired)—idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Delayed puberty, provided it has been definitely established as such, and is not just a familial trait. In the female—ORA-TESTRYL Tablets are indicated for palliation of androgen-responsive recurrent mammary cancer in women who are more than one year but less than five years postmenopausal, or who have been proven to have a hormone- dependent tumor as shown by previous beneficial response to castration.
0 0 0
Total Other Developers None
Drugs with Suitability No
2MG ** ** - - -
5MG ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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