APPLICATION
ANDA089420
TYPE
ANDA
ORIGINAL APPROVAL
1988-01-25
LATEST ACTION
1999-11-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AZDONEDiscontinued
ASPIRIN 500MG, HYDROCODONE BITARTRATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1999-11-29Manufacturing (CMC) · Supplement 24AP
1999-09-14Labeling · Supplement 26AP
1999-06-22Labeling · Supplement 25AP
1995-02-23Labeling · Supplement 20AP
1995-02-23Manufacturing (CMC) · Supplement 19AP
1995-02-23Manufacturing (CMC) · Supplement 21AP
1993-04-30Manufacturing (CMC) · Supplement 18AP
1993-04-30Manufacturing (CMC) · Supplement 16AP
1993-04-30Labeling · Supplement 17AP
1992-09-30Manufacturing (CMC) · Supplement 12AP
1992-04-16Manufacturing (CMC) · Supplement 8AP
1991-07-29Manufacturing (CMC) · Supplement 5AP
1991-07-29Manufacturing (CMC) · Supplement 13AP
1991-03-22Labeling · Supplement 11AP
1990-07-06Labeling · Supplement 2AP
1990-07-06Manufacturing (CMC) · Supplement 3AP
1988-06-15Manufacturing (CMC) · Supplement 1AP
1988-01-25OriginalAP
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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