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FDA ANDA · ANDA075109

GUANFACINE HYDROCHLORIDE

guanfacine

Sponsor: AMNEAL PHARM

APPLICATION
ANDA075109
TYPE
ANDA
ORIGINAL APPROVAL
1998-11-25
LATEST ACTION
2014-02-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL

Approval history

2014-02-19Manufacturing (CMC) · Supplement 5AP
2002-11-04Labeling · Supplement 3AP
2001-06-22Manufacturing (CMC) · Supplement 1AP
1998-11-25OriginalAP
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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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