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FDA ANDA · ANDA072655

AMANTADINE HYDROCHLORIDE

Sponsor: G AND W LABS INC

APPLICATION
ANDA072655
TYPE
ANDA
ORIGINAL APPROVAL
1990-10-30
LATEST ACTION
2011-07-29
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

AMANTADINE HYDROCHLORIDEDiscontinued
AMANTADINE HYDROCHLORIDE 50MG/5ML · SYRUP · ORAL

Approval history

2011-07-29Labeling · Supplement 18AP
1998-12-16Manufacturing (CMC) · Supplement 11AP
1997-09-08Manufacturing (CMC) · Supplement 9AP
1994-01-13Labeling · Supplement 8AP
1993-08-10Manufacturing (CMC) · Supplement 6AP
1993-08-10Manufacturing (CMC) · Supplement 7AP
1993-08-10Manufacturing (CMC) · Supplement 5AP
1992-11-02Manufacturing (CMC) · Supplement 4AP
1991-12-30Labeling · Supplement 3AP
1991-09-04Labeling · Supplement 1AP
1990-10-30OriginalAP
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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