APPLICATION
ANDA071785
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-05
LATEST ACTION
2017-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.1MG · TABLET · ORAL
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.2MG · TABLET · ORAL
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.3MG · TABLET · ORAL
Approval history
2017-06-08Labeling · Supplement 19 · standardAP
2006-10-05Labeling · Supplement 13AP
2000-09-18Manufacturing (CMC) · Supplement 11AP
1998-05-18Manufacturing (CMC) · Supplement 10AP
1997-02-18Labeling · Supplement 9AP
1996-11-13Manufacturing (CMC) · Supplement 8AP
1994-07-26Manufacturing (CMC) · Supplement 7AP
1990-01-03Labeling · Supplement 6AP
1989-10-18Labeling · Supplement 5AP
1988-05-12Labeling · Supplement 2AP
1988-05-12Manufacturing (CMC) · Supplement 1AP
1988-04-05OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.