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FDA ANDA · ANDA074744

SELEGILINE HYDROCHLORIDE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA074744
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-27
LATEST ACTION
1999-12-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SELEGILINE HYDROCHLORIDEDiscontinued
SELEGILINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

1999-12-02Manufacturing (CMC) · Supplement 8AP
1999-12-02Manufacturing (CMC) · Supplement 9AP
1999-02-12Manufacturing (CMC) · Supplement 4AP
1999-02-12Manufacturing (CMC) · Supplement 3AP
1998-09-28Labeling · Supplement 2AP
1997-06-18Labeling · Supplement 1AP
1997-01-27OriginalAP
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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