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FDA ANDA · ANDA071145

IBUPROFEN

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA071145
TYPE
ANDA
ORIGINAL APPROVAL
1986-09-23
LATEST ACTION
1997-05-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 400MG · TABLET · ORAL

Approval history

1997-05-05Manufacturing (CMC) · Supplement 19AP
1992-12-16Manufacturing (CMC) · Supplement 17AP
1992-12-16Manufacturing (CMC) · Supplement 18AP
1991-06-12Labeling · Supplement 16AP
1990-12-07Manufacturing (CMC) · Supplement 15AP
1990-12-07Manufacturing (CMC) · Supplement 11AP
1990-12-07Manufacturing (CMC) · Supplement 14AP
1989-02-01Labeling · Supplement 13AP
1989-02-01Labeling · Supplement 12AP
1989-01-11Manufacturing (CMC) · Supplement 10AP
1988-06-30Manufacturing (CMC) · Supplement 7AP
1988-06-30Manufacturing (CMC) · Supplement 8AP
1988-06-30Manufacturing (CMC) · Supplement 6AP
1988-04-06Manufacturing (CMC) · Supplement 5AP
1988-04-06Manufacturing (CMC) · Supplement 4AP
1987-08-25Manufacturing (CMC) · Supplement 2AP
1986-09-23OriginalAP
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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