← FDA DRUG APPROVALS

FDA ANDA · ANDA074537

SELEGILINE HYDROCHLORIDE

Sponsor: G AND W LABS INC

APPLICATION
ANDA074537
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-02
LATEST ACTION
1999-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SELEGILINE HYDROCHLORIDEDiscontinued
SELEGILINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

1999-04-23Manufacturing (CMC) · Supplement 3AP
1998-06-09Labeling · Supplement 2AP
1997-06-10Labeling · Supplement 1AP
1996-08-02OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →