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FDA NDA · NDA018197

IBU

Sponsor: BASF

APPLICATION
NDA018197
TYPE
NDA
ORIGINAL APPROVAL
1981-05-21
LATEST ACTION
1995-03-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUDiscontinued
IBUPROFEN 400MG · TABLET · ORAL
RUFENDiscontinued
IBUPROFEN 600MG · TABLET · ORAL

Approval history

1995-03-06Labeling · Supplement 30AP
1995-01-05Labeling · Supplement 29AP
1991-10-09Labeling · Supplement 27AP
1989-10-25Labeling · Supplement 26AP
1989-01-19Labeling · Supplement 24AP
1989-01-17Labeling · Supplement 22AP
1988-10-28Labeling · Supplement 23AP
1986-07-01Manufacturing (CMC) · Supplement 20AP
1986-01-17Manufacturing (CMC) · Supplement 16AP
1986-01-17Manufacturing (CMC) · Supplement 19AP
1986-01-17Manufacturing (CMC) · Supplement 17AP
1986-01-17Manufacturing (CMC) · Supplement 15AP
1985-05-01Manufacturing (CMC) · Supplement 12AP
1981-05-21OriginalAP
VIEW ON DRUGS@FDA ↗

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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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