APPLICATION
ANDA074145
TYPE
ANDA
ORIGINAL APPROVAL
1995-10-17
LATEST ACTION
2016-11-30
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
2016-11-30Labeling · Supplement 21 · standardAP
2003-07-16Labeling · Supplement 9AP
2002-08-05Manufacturing (CMC) · Supplement 8AP
2002-05-21Manufacturing (CMC) · Supplement 6AP
2001-09-27Manufacturing (CMC) · Supplement 3AP
2001-09-05Manufacturing (CMC) · Supplement 5AP
1999-11-10Manufacturing (CMC) · Supplement 2AP
1998-03-18Manufacturing (CMC) · Supplement 1AP
1995-10-17OriginalAP
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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