APPLICATION
ANDA070435
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-05
LATEST ACTION
1992-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
Approval history
1992-09-23Manufacturing (CMC) · Supplement 12AP
1992-01-30Manufacturing (CMC) · Supplement 13AP
1992-01-30Manufacturing (CMC) · Supplement 14AP
1990-11-19Manufacturing (CMC) · Supplement 18AP
1990-06-29Manufacturing (CMC) · Supplement 16AP
1989-06-08Bioequivalence · Supplement 35AP
1986-10-20Manufacturing (CMC) · Supplement 7AP
1986-10-20Manufacturing (CMC) · Supplement 10AP
1986-10-20Manufacturing (CMC) · Supplement 6AP
1986-10-20Manufacturing (CMC) · Supplement 9AP
1986-08-25Manufacturing (CMC) · Supplement 4AP
1986-04-30Manufacturing (CMC) · Supplement 1AP
1986-03-25Manufacturing (CMC) · Supplement 2AP
1986-03-05OriginalAP
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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