APPLICATION
ANDA087716
TYPE
ANDA
ORIGINAL APPROVAL
1990-10-03
LATEST ACTION
2006-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DIPYRIDAMOLEPrescription
DIPYRIDAMOLE 50MG · TABLET · ORAL
Approval history
2006-08-18Labeling · Supplement 41AP
2005-10-05Labeling · Supplement 37AP
2002-05-15Manufacturing (CMC) · Supplement 34AP
2002-05-15Manufacturing (CMC) · Supplement 35AP
2002-05-15Manufacturing (CMC) · Supplement 33AP
1999-12-21Manufacturing (CMC) · Supplement 32AP
1999-05-20Manufacturing (CMC) · Supplement 31AP
1998-12-01Manufacturing (CMC) · Supplement 30AP
1998-03-30Manufacturing (CMC) · Supplement 29AP
1997-02-10Manufacturing (CMC) · Supplement 28AP
1996-08-13Manufacturing (CMC) · Supplement 26AP
1996-04-17Manufacturing (CMC) · Supplement 27AP
1992-08-13Labeling · Supplement 22AP
1992-04-03Manufacturing (CMC) · Supplement 21AP
1992-04-03Manufacturing (CMC) · Supplement 19AP
1991-08-30Manufacturing (CMC) · Supplement 18AP
1990-10-03OriginalAP
1990-10-03Labeling · Supplement 12AP
1990-03-29Bioequivalence · Supplement 17AP
1988-01-07Manufacturing (CMC) · Supplement 16AP
1987-09-28Manufacturing (CMC) · Supplement 15AP
1987-09-28Manufacturing (CMC) · Supplement 14AP
1987-03-25Manufacturing (CMC) · Supplement 11AP
1984-08-15Manufacturing (CMC) · Supplement 1AP
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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