APPLICATION
NDA019833
TYPE
NDA
ORIGINAL APPROVAL
1989-09-19
LATEST ACTION
1998-05-08
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
CHILDREN'S ADVILDiscontinued
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
Approval history
1998-05-08Manufacturing (CMC) · Supplement 12 · standardAP
1994-10-24Manufacturing (CMC) · Supplement 8 · standardAP
1994-07-27Manufacturing (CMC) · Supplement 2 · standardAP
1994-04-25Manufacturing (CMC) · Supplement 1 · standardAP
1994-04-21Manufacturing (CMC) · Supplement 5 · standardAP
1991-11-27Manufacturing (CMC) · Supplement 7 · standardAP
1989-09-19Type 3 - New Dosage Form · 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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