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FDA ANDA · ANDA202297

CLONIDINE HYDROCHLORIDE

Sponsor: YUNG SHIN PHARM

APPLICATION
ANDA202297
TYPE
ANDA
ORIGINAL APPROVAL
2013-06-13
LATEST ACTION
2024-12-23
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

2024-12-23Manufacturing (CMC) · Supplement 6 · unknownAP
2013-06-13OriginalAP
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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