mitotane tablets
for oral use Initial U.S. Approval: 1970

mitotane is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.

Facts about Mitotane tablets

Approval Date: 1970
Proprietary Name: On Request
Active Ingredient(s): Mitotane tablets
Dosage Forms And Strengths: Tablets: 500 mg, scored
Manufacturer: Bristol-Myers Squibb Company 
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA approved use on approval date: Click Here
(see Drugs@FDA for complete indication)

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