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FDA ANDA · ANDA070099

IBU

Sponsor: BASF

APPLICATION
ANDA070099
TYPE
ANDA
ORIGINAL APPROVAL
1985-03-29
LATEST ACTION
1995-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUDiscontinued
IBUPROFEN 600MG · TABLET · ORAL

Approval history

1995-08-11Manufacturing (CMC) · Supplement 26AP
1995-02-15Labeling · Supplement 27AP
1992-08-03Manufacturing (CMC) · Supplement 21AP
1992-08-03Manufacturing (CMC) · Supplement 22AP
1992-03-20Labeling · Supplement 24AP
1991-10-17Labeling · Supplement 23AP
1991-08-06Labeling · Supplement 20AP
1990-08-16Manufacturing (CMC) · Supplement 19AP
1989-10-27Labeling · Supplement 18AP
1989-01-10Labeling · Supplement 16AP
1988-10-07Labeling · Supplement 15AP
1988-02-08Labeling · Supplement 14AP
1987-08-27Manufacturing (CMC) · Supplement 10AP
1987-08-27Manufacturing (CMC) · Supplement 9AP
1986-05-20Manufacturing (CMC) · Supplement 7AP
1986-05-20Manufacturing (CMC) · Supplement 6AP
1986-01-17Manufacturing (CMC) · Supplement 3AP
1986-01-17Manufacturing (CMC) · Supplement 4AP
1986-01-17Manufacturing (CMC) · Supplement 2AP
1985-03-29OriginalAP
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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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