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FDA ANDA · ANDA074641

SELEGILINE HYDROCHLORIDE

Sponsor: CHARTWELL MOLECULES

APPLICATION
ANDA074641
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-02
LATEST ACTION
2001-07-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SELEGILINE HYDROCHLORIDEDiscontinued
SELEGILINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2001-07-25Manufacturing (CMC) · Supplement 6AP
2001-07-25Manufacturing (CMC) · Supplement 5AP
1999-08-31Labeling · Supplement 4AP
1998-09-18Manufacturing (CMC) · Supplement 3AP
1998-04-08Labeling · Supplement 2AP
1997-07-11Labeling · Supplement 1AP
1996-08-02OriginalAP
VIEW ON DRUGS@FDA ↗

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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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