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FDA ANDA · ANDA070923

CLONIDINE HYDROCHLORIDE

Sponsor: TP ANDA HOLDINGS

APPLICATION
ANDA070923
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-04
LATEST ACTION
2013-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.05MG · TABLET · ORAL
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.2MG · TABLET · ORAL
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.1MG · TABLET · ORAL
CLONIDINE HYDROCHLORIDEPrescription
CLONIDINE HYDROCHLORIDE 0.3MG · TABLET · ORAL

Approval history

2013-01-17Labeling · Supplement 31 · standardAP
2010-05-10Labeling · Supplement 30AP
2010-03-11Labeling · Supplement 29AP
2005-10-06Labeling · Supplement 19AP
1998-12-01Manufacturing (CMC) · Supplement 15AP
1997-06-23Labeling · Supplement 14AP
1994-12-23Manufacturing (CMC) · Supplement 13AP
1994-10-11Manufacturing (CMC) · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1989-08-03Labeling · Supplement 8AP
1989-04-21Labeling · Supplement 5AP
1989-04-21Manufacturing (CMC) · Supplement 6AP
1988-09-28Labeling · Supplement 4AP
1988-01-20Manufacturing (CMC) · Supplement 1AP
1987-09-04OriginalAP
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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