APPLICATION
NDA016030
TYPE
NDA
ORIGINAL APPROVAL
1965-06-25
LATEST ACTION
1995-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
MEASURINDiscontinued
ASPIRIN 650MG · TABLET, EXTENDED RELEASE · ORAL
8-HOUR BAYERDiscontinued
ASPIRIN 650MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1995-10-25Manufacturing (CMC) · Supplement 43 · standardAP
1994-04-21Manufacturing (CMC) · Supplement 42 · standardAP
1991-10-23Manufacturing (CMC) · Supplement 41 · standardAP
1990-09-17Manufacturing (CMC) · Supplement 40 · standardAP
1987-09-23Manufacturing (CMC) · Supplement 38 · standardAP
1987-09-23Manufacturing (CMC) · Supplement 39 · standardAP
1986-06-20Labeling · Supplement 36 · standardAP
1986-06-20Labeling · Supplement 34 · standardAP
1986-06-20Labeling · Supplement 37 · standardAP
1986-06-20Labeling · Supplement 35 · standardAP
1985-02-04Manufacturing (CMC) · Supplement 33 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 32 · standardAP
1983-10-25Manufacturing (CMC) · Supplement 31 · standardAP
1983-09-09Manufacturing (CMC) · Supplement 30 · standardAP
1983-06-08Manufacturing (CMC) · Supplement 27 · standardAP
1983-04-14Labeling · Supplement 29 · standardAP
1983-04-07Manufacturing (CMC) · Supplement 26 · standardAP
1983-01-11Manufacturing (CMC) · Supplement 28 · standardAP
1982-01-06Manufacturing (CMC) · Supplement 25 · standardAP
1980-10-17Manufacturing (CMC) · Supplement 24 · standardAP
1980-02-28Manufacturing (CMC) · Supplement 23 · standardAP
1979-07-24Manufacturing (CMC) · Supplement 21 · standardAP
1979-07-24Manufacturing (CMC) · Supplement 22 · standardAP
1979-03-02Manufacturing (CMC) · Supplement 20 · standardAP
1975-12-12Manufacturing (CMC) · Supplement 17 · standardAP
1965-06-25Type 3 - New Dosage Form · Original · standardAP
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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