APPLICATION
ANDA073019
TYPE
ANDA
ORIGINAL APPROVAL
1994-03-30
LATEST ACTION
1998-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 200MG · TABLET · ORAL
Approval history
1998-10-07Manufacturing (CMC) · Supplement 8AP
1998-10-07Labeling · Supplement 6 · standardAP
1998-10-07Manufacturing (CMC) · Supplement 9AP
1998-10-07Manufacturing (CMC) · Supplement 7AP
1997-11-28Labeling · Supplement 2 · standardAP
1997-11-28Manufacturing (CMC) · Supplement 5AP
1997-11-28Manufacturing (CMC) · Supplement 1AP
1997-07-09Manufacturing (CMC) · Supplement 10AP
1994-10-07Manufacturing (CMC) · Supplement 4AP
1994-10-07Manufacturing (CMC) · Supplement 3AP
1994-03-30UNKNOWN · Original · unknownAP
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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