Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Labeling for ORETON Buccal Tablet (Methyltestosterone 10 mg) – ANDA080281
The FDA approved labeling for SCHERING's ORETON buccal tablet containing 10 mg methyltestosterone (application ANDA080281). The product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Lilly Methyltestosterone Tablet ANDA080256 (Discontinued)
FDA approved Lilly's ANDA080256 for methyltestosterone tablets (10 mg and 25 mg) buccal/sublingual on Dec 22 1971; both products are now discontinued.