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FDA ANDA · ANDA077901

CLONIDINE HYDROCHLORIDE

Sponsor: PRINSTON INC

APPLICATION
ANDA077901
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-09
LATEST ACTION
2015-07-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.2MG · TABLET · ORAL
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.3MG · TABLET · ORAL
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.1MG · TABLET · ORAL

Approval history

2015-07-13Labeling · Supplement 5 · standardAP
2010-05-27Labeling · Supplement 2AP
2007-03-09OriginalAP
VIEW ON DRUGS@FDA ↗

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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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