APPLICATION
ANDA075217
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-16
LATEST ACTION
2011-05-24
ROUTE
ORAL
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 40MG/ML · SUSPENSION/DROPS · ORAL
Approval history
2011-05-24Labeling · Supplement 38AP
2006-03-22Labeling · Supplement 26AP
2003-05-22Labeling · Supplement 9AP
2001-08-21Manufacturing (CMC) · Supplement 6AP
2001-06-14Manufacturing (CMC) · Supplement 5AP
2000-10-18Labeling · Supplement 4AP
2000-05-24Labeling · Supplement 3AP
2000-05-24Manufacturing (CMC) · Supplement 2AP
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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