APPLICATION
ANDA201382
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-02
LATEST ACTION
2020-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 3MG BASE · TABLET, EXTENDED RELEASE · ORAL
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 1MG BASE · TABLET, EXTENDED RELEASE · ORAL
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 2MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-05-27Labeling · Supplement 7 · standardAP
2019-11-06Labeling · Supplement 6 · standardAP
2019-11-06Labeling · Supplement 4 · standardAP
2019-11-06Labeling · Supplement 5 · standardAP
2019-11-06Labeling · Supplement 3 · standardAP
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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