APPLICATION
NDA017407
TYPE
NDA
ORIGINAL APPROVAL
1974-09-03
LATEST ACTION
2015-05-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CATAPRES · ReferenceDiscontinued
CLONIDINE HYDROCHLORIDE 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CATAPRES · ReferenceDiscontinued
CLONIDINE HYDROCHLORIDE 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CATAPRES · ReferenceDiscontinued
CLONIDINE HYDROCHLORIDE 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2015-05-21Manufacturing (CMC) · Supplement 38 · priorityAP
1999-04-13Manufacturing (CMC) · Supplement 31 · priorityAP
1998-04-30Manufacturing (CMC) · Supplement 30 · priorityAP
1997-11-03Manufacturing (CMC) · Supplement 29 · priorityAP
1996-08-02Labeling · Supplement 28 · standardAP
1996-08-02Labeling · Supplement 27 · standardAP
1988-06-20Labeling · Supplement 26AP
1987-09-08Labeling · Supplement 19AP
1987-09-02Manufacturing (CMC) · Supplement 24 · priorityAP
1987-03-26Labeling · Supplement 25AP
1986-04-11Labeling · Supplement 23AP
1985-10-02Labeling · Supplement 22AP
1985-03-06Manufacturing (CMC) · Supplement 21 · priorityAP
1984-04-06Manufacturing (CMC) · Supplement 20 · priorityAP
1982-11-03Manufacturing (CMC) · Supplement 18 · priorityAP
1981-08-05Manufacturing (CMC) · Supplement 17 · priorityAP
1981-04-06Manufacturing (CMC) · Supplement 16 · priorityAP
1981-02-20Manufacturing (CMC) · Supplement 14 · priorityAP
1981-02-20Manufacturing (CMC) · Supplement 15 · priorityAP
1981-02-05Manufacturing (CMC) · Supplement 6 · priorityAP
1980-12-10Manufacturing (CMC) · Supplement 10 · priorityAP
1980-09-16Manufacturing (CMC) · Supplement 12 · priorityAP
1980-09-12Manufacturing (CMC) · Supplement 13 · priorityAP
1980-02-26Manufacturing (CMC) · Supplement 11 · priorityAP
1979-09-20Efficacy · Supplement 8AP
1978-11-27Manufacturing (CMC) · Supplement 9 · priorityAP
1977-01-17Manufacturing (CMC) · Supplement 4 · priorityAP
1976-12-10Manufacturing (CMC) · Supplement 5 · priorityAP
1976-10-27Manufacturing (CMC) · Supplement 3 · priorityAP
1976-07-26Manufacturing (CMC) · Supplement 2 · priorityAP
1976-06-08Manufacturing (CMC) · Supplement 1 · priorityAP
1974-09-03Type 3 - New Dosage Form · Original · priorityAP
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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