APPLICATION
ANDA203320
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-15
LATEST ACTION
2020-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued, Prescription
Products
CLONIDINE HYDROCHLORIDEDiscontinued
CLONIDINE HYDROCHLORIDE 0.2MG · TABLET, EXTENDED RELEASE · ORAL
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.1MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-05-27Labeling · Supplement 4 · standardAP
2020-05-27Labeling · Supplement 8 · standardAP
2015-10-13Labeling · Supplement 2 · standardAP
2015-10-13Manufacturing (CMC) · Supplement 1 · unknownAP
2015-05-15UNKNOWN · OriginalAP
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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