APPLICATION
ANDA074565
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-02
LATEST ACTION
2025-09-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SELEGILINE HYDROCHLORIDEDiscontinued
SELEGILINE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2025-09-04Labeling · Supplement 8 · standardAP
2002-07-18Manufacturing (CMC) · Supplement 6AP
2002-04-09Manufacturing (CMC) · Supplement 5AP
1998-09-28Labeling · Supplement 4AP
1997-01-29Labeling · Supplement 1AP
1997-01-16Manufacturing (CMC) · Supplement 2AP
1997-01-16Manufacturing (CMC) · Supplement 3AP
1996-08-02OriginalAP
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.
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