APPLICATION
ANDA205430
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-25
LATEST ACTION
2024-02-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 2MG BASE · TABLET, EXTENDED RELEASE · ORAL
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 3MG BASE · TABLET, EXTENDED RELEASE · ORAL
GUANFACINE HYDROCHLORIDEPrescription
GUANFACINE HYDROCHLORIDE EQ 1MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-02-20Labeling · Supplement 5 · standardAP
2020-10-29Labeling · Supplement 2 · standardAP
2019-07-30Labeling · Supplement 1 · standardAP
2018-07-25UNKNOWN · Original · 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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