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FDA ANDA · ANDA087717

DIPYRIDAMOLE

Sponsor: BARR LABS

APPLICATION
ANDA087717
TYPE
ANDA
ORIGINAL APPROVAL
1990-10-03
LATEST ACTION
2006-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DIPYRIDAMOLEPrescription
DIPYRIDAMOLE 75MG · TABLET · ORAL

Approval history

2006-08-18Labeling · Supplement 39AP
2005-10-05Labeling · Supplement 35AP
2001-03-07Manufacturing (CMC) · Supplement 33AP
2001-03-07Manufacturing (CMC) · Supplement 32AP
1999-12-21Manufacturing (CMC) · Supplement 31AP
1999-05-20Manufacturing (CMC) · Supplement 30AP
1998-12-01Manufacturing (CMC) · Supplement 29AP
1998-03-30Manufacturing (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 19AP
1992-04-03Manufacturing (CMC) · Supplement 21AP
1991-08-30Manufacturing (CMC) · Supplement 18AP
1990-10-03Labeling · Supplement 12AP
1990-10-03OriginalAP
1990-03-15Bioequivalence · Supplement 17AP
1987-10-07Manufacturing (CMC) · Supplement 16AP
1987-09-15Manufacturing (CMC) · Supplement 14AP
1987-09-15Manufacturing (CMC) · Supplement 15AP
1987-03-25Manufacturing (CMC) · Supplement 11AP
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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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