APPLICATION
ANDA074871
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-06
LATEST ACTION
2009-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SELEGILINE HYDROCHLORIDEPrescription
SELEGILINE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2009-12-01Labeling · Supplement 9AP
1999-08-18Manufacturing (CMC) · Supplement 4AP
1999-06-16Manufacturing (CMC) · Supplement 1AP
1999-06-16Labeling · Supplement 2AP
1998-10-20Labeling · Supplement 3AP
1997-06-06OriginalAP
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.