APPLICATION
ANDA086944
TYPE
ANDA
ORIGINAL APPROVAL
1991-04-16
LATEST ACTION
2024-01-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DIPYRIDAMOLEDiscontinued
DIPYRIDAMOLE 25MG · TABLET · ORAL
DIPYRIDAMOLEDiscontinued
DIPYRIDAMOLE 75MG · TABLET · ORAL
DIPYRIDAMOLEDiscontinued
DIPYRIDAMOLE 50MG · TABLET · ORAL
Approval history
2024-01-12Manufacturing (CMC) · Supplement 41 · unknownAP
2001-05-09Manufacturing (CMC) · Supplement 36AP
1995-01-12Manufacturing (CMC) · Supplement 35AP
1992-03-12Labeling · Supplement 34AP
1991-04-16OriginalAP
1991-04-16Labeling · Supplement 31AP
1989-11-20Labeling · Supplement 32AP
1989-04-26Bioequivalence · Supplement 30AP
1986-11-20Manufacturing (CMC) · Supplement 29AP
1986-07-03Manufacturing (CMC) · Supplement 28AP
1986-05-27Manufacturing (CMC) · Supplement 27AP
1985-04-30Manufacturing (CMC) · Supplement 26AP
1985-04-30Manufacturing (CMC) · Supplement 20AP
1984-08-21Manufacturing (CMC) · Supplement 24AP
1983-12-13Manufacturing (CMC) · Supplement 21AP
1982-07-20Manufacturing (CMC) · Supplement 18AP
1982-07-20Manufacturing (CMC) · Supplement 19AP
1982-07-20Manufacturing (CMC) · Supplement 17AP
1982-03-10Manufacturing (CMC) · Supplement 14AP
1982-03-10Manufacturing (CMC) · Supplement 15AP
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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