APPLICATION
NDA017463
TYPE
NDA
ORIGINAL APPROVAL
1974-09-19
LATEST ACTION
2007-09-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MOTRIN · ReferenceDiscontinued
IBUPROFEN 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MOTRIN · ReferenceDiscontinued
IBUPROFEN 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MOTRIN · ReferenceDiscontinued
IBUPROFEN 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MOTRIN · ReferenceDiscontinued
IBUPROFEN 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-06-20Manufacturing (CMC) · Supplement 102 · priorityAP
2001-05-14Manufacturing (CMC) · Supplement 103 · priorityAP
1999-11-29Manufacturing (CMC) · Supplement 101 · priorityAP
1999-07-20Manufacturing (CMC) · Supplement 99 · priorityAP
1995-11-20Manufacturing (CMC) · Supplement 98 · priorityAP
1995-11-15Manufacturing (CMC) · Supplement 97 · priorityAP
1995-03-23Manufacturing (CMC) · Supplement 95 · priorityAP
1994-06-22Manufacturing (CMC) · Supplement 85 · priorityAP
1992-10-19Manufacturing (CMC) · Supplement 91 · priorityAP
1990-12-26Manufacturing (CMC) · Supplement 89 · priorityAP
1990-10-31Manufacturing (CMC) · Supplement 68 · priorityAP
1990-10-02Manufacturing (CMC) · Supplement 82 · priorityAP
1989-07-25Manufacturing (CMC) · Supplement 87 · priorityAP
1988-02-16Labeling · Supplement 78 · priorityAP
1988-02-16Labeling · Supplement 79 · priorityAP
1988-02-16Labeling · Supplement 77 · priorityAP
1987-11-27Labeling · Supplement 75 · priorityAP
1986-12-22Manufacturing (CMC) · Supplement 65 · priorityAP
1986-12-16Manufacturing (CMC) · Supplement 74 · priorityAP
1986-10-10Labeling · Supplement 71 · priorityAP
1986-10-10Labeling · Supplement 72 · priorityAP
1986-10-10Manufacturing (CMC) · Supplement 70 · priorityAP
1985-11-06Labeling · Supplement 69 · priorityAP
1985-05-22Labeling · Supplement 63 · priorityAP
1985-05-22Labeling · Supplement 53 · priorityAP
1984-05-29Manufacturing (CMC) · Supplement 62 · priorityAP
1983-04-09Labeling · Supplement 57 · priorityAP
1982-03-01Labeling · Supplement 49 · priorityAP
1982-03-01Labeling · Supplement 46 · priorityAP
1982-03-01Labeling · Supplement 52 · priorityAP
1981-07-02Manufacturing (CMC) · Supplement 51 · priorityAP
1981-07-02Manufacturing (CMC) · Supplement 50 · priorityAP
1981-03-31Labeling · Supplement 48 · priorityAP
1980-09-12Manufacturing (CMC) · Supplement 47 · priorityAP
1980-01-31Manufacturing (CMC) · Supplement 44 · priorityAP
1979-12-21Manufacturing (CMC) · Supplement 45 · priorityAP
1979-08-21Efficacy · Supplement 40 · priorityAP
1979-08-21Labeling · Supplement 24 · priorityAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.