APPLICATION
NDA018297
TYPE
NDA
ORIGINAL APPROVAL
1980-06-10
LATEST ACTION
1986-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LOPURINDiscontinued
ALLOPURINOL 100MG · TABLET · ORAL
LOPURINDiscontinued
ALLOPURINOL 300MG · TABLET · ORAL
Approval history
1986-07-21Manufacturing (CMC) · Supplement 15 · standardAP
1986-03-18Manufacturing (CMC) · Supplement 14 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 9 · standardAP
1985-11-18Manufacturing (CMC) · Supplement 11 · standardAP
1985-05-31Manufacturing (CMC) · Supplement 13 · standardAP
1985-03-06Manufacturing (CMC) · Supplement 10 · standardAP
1985-02-15Manufacturing (CMC) · Supplement 6 · standardAP
1982-01-11Manufacturing (CMC) · Supplement 3 · standardAP
1982-01-11Manufacturing (CMC) · Supplement 2 · standardAP
1981-06-10Manufacturing (CMC) · Supplement 4 · standardAP
1981-04-27Labeling · Supplement 1 · standardAP
1981-03-25Manufacturing (CMC) · Supplement 7 · standardAP
1980-06-10Type 5 - New Formulation or New Manufacturer · 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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