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FDA ANDA · ANDA070493

IBUPROFEN

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA070493
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-24
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 28AP
1994-12-23Manufacturing (CMC) · Supplement 26AP
1994-10-11Manufacturing (CMC) · Supplement 25AP
1993-05-18Labeling · Supplement 24AP
1993-05-18Labeling · Supplement 20AP
1992-04-03Manufacturing (CMC) · Supplement 21AP
1992-04-03Manufacturing (CMC) · Supplement 23AP
1991-11-01Labeling · Supplement 18AP
1988-12-19Manufacturing (CMC) · Supplement 14AP
1988-08-02Manufacturing (CMC) · Supplement 13AP
1988-08-02Manufacturing (CMC) · Supplement 11AP
1987-05-07Manufacturing (CMC) · Supplement 10AP
1987-01-28Manufacturing (CMC) · Supplement 8AP
1987-01-28Manufacturing (CMC) · Supplement 9AP
1986-09-29Manufacturing (CMC) · Supplement 6AP
1986-09-29Manufacturing (CMC) · Supplement 5AP
1986-09-12Manufacturing (CMC) · Supplement 3AP
1986-09-12Manufacturing (CMC) · Supplement 1AP
1986-07-10Manufacturing (CMC) · Supplement 2AP
1985-12-24OriginalAP
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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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