APPLICATION
ANDA073345
TYPE
ANDA
ORIGINAL APPROVAL
1992-06-30
LATEST ACTION
1999-12-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 800MG · TABLET · ORAL
Approval history
1999-12-02Manufacturing (CMC) · Supplement 10AP
1999-12-02Manufacturing (CMC) · Supplement 9AP
1999-02-12Manufacturing (CMC) · Supplement 4AP
1999-02-12Manufacturing (CMC) · Supplement 3AP
1998-08-28Manufacturing (CMC) · Supplement 2AP
1993-02-03Manufacturing (CMC) · Supplement 1AP
1992-06-30OriginalAP
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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