APPLICATION
ANDA080256
TYPE
ANDA
ORIGINAL APPROVAL
1971-12-22
LATEST ACTION
1971-12-22
ROUTE
BUCCAL, SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLTESTOSTERONEDiscontinued
METHYLTESTOSTERONE 25MG · TABLET · BUCCAL, SUBLINGUAL
METHYLTESTOSTERONEDiscontinued
METHYLTESTOSTERONE 10MG · TABLET · BUCCAL, SUBLINGUAL
Approval history
1971-12-22OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.