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FDA ANDA · ANDA070083

IBU

Sponsor: BASF

APPLICATION
ANDA070083
TYPE
ANDA
ORIGINAL APPROVAL
1985-02-22
LATEST ACTION
1995-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUDiscontinued
IBUPROFEN 400MG · TABLET · ORAL

Approval history

1995-08-11Manufacturing (CMC) · Supplement 19AP
1995-02-15Labeling · Supplement 20AP
1994-09-30Manufacturing (CMC) · Supplement 18AP
1994-09-30Manufacturing (CMC) · Supplement 17AP
1993-05-03Labeling · Supplement 16AP
1992-03-11Labeling · Supplement 15AP
1991-10-24Labeling · Supplement 14AP
1991-08-06Labeling · Supplement 13AP
1989-09-06Labeling · Supplement 12AP
1989-02-14Labeling · Supplement 10AP
1989-02-14Manufacturing (CMC) · Supplement 9AP
1988-03-01Labeling · Supplement 8AP
1986-05-23Manufacturing (CMC) · Supplement 6AP
1986-01-16Manufacturing (CMC) · Supplement 4AP
1986-01-16Manufacturing (CMC) · Supplement 2AP
1986-01-16Manufacturing (CMC) · Supplement 5AP
1986-01-16Manufacturing (CMC) · Supplement 3AP
1985-02-22OriginalAP
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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