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FDA ANDA · ANDA074796
GUANFACINE
guanfacine hydrochloride
Sponsor: AUROBINDO PHARMA USA
APPLICATION
ANDA074796
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-27
LATEST ACTION
2016-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
Approval history
2016-08-22Labeling · Supplement 11 · standardAP
2003-07-16Labeling · Supplement 3AP
2002-12-12Manufacturing (CMC) · Supplement 2AP
1998-12-23Manufacturing (CMC) · Supplement 1AP
1997-01-27OriginalAP
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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