APPLICATION
ANDA070974
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-16
LATEST ACTION
2013-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.1MG · TABLET · ORAL
Approval history
2013-01-16Labeling · Supplement 40 · standardAP
2010-06-23Labeling · Supplement 34AP
2002-08-08Manufacturing (CMC) · Supplement 16AP
2001-11-02Manufacturing (CMC) · Supplement 15AP
2000-03-20Manufacturing (CMC) · Supplement 13AP
2000-03-20Manufacturing (CMC) · Supplement 14AP
1997-02-18Labeling · Supplement 12AP
1996-01-18Manufacturing (CMC) · Supplement 10AP
1992-02-04Manufacturing (CMC) · Supplement 9AP
1990-11-21Manufacturing (CMC) · Supplement 7AP
1989-10-13Labeling · Supplement 8AP
1988-11-17Labeling · Supplement 6AP
1988-11-17Labeling · Supplement 5AP
1988-01-28Manufacturing (CMC) · Supplement 4AP
1987-06-09Manufacturing (CMC) · Supplement 2AP
1987-06-09Manufacturing (CMC) · Supplement 1AP
1986-12-16OriginalAP
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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