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FDA ANDA · ANDA070818

IBUPROFEN

Sponsor: OHM LABS

APPLICATION
ANDA070818
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-26
LATEST ACTION
1994-08-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 400MG · TABLET · ORAL

Approval history

1994-08-05Manufacturing (CMC) · Supplement 13AP
1992-09-21Manufacturing (CMC) · Supplement 11AP
1991-11-21Manufacturing (CMC) · Supplement 10AP
1991-11-21Manufacturing (CMC) · Supplement 9AP
1991-08-22Labeling · Supplement 12AP
1990-08-07Manufacturing (CMC) · Supplement 7AP
1989-06-01Labeling · Supplement 8AP
1989-03-16Labeling · Supplement 6AP
1989-01-10Manufacturing (CMC) · Supplement 5AP
1988-06-07Manufacturing (CMC) · Supplement 4AP
1988-06-06Manufacturing (CMC) · Supplement 2AP
1988-05-11Manufacturing (CMC) · Supplement 3AP
1988-02-11Manufacturing (CMC) · Supplement 1AP
1985-12-26OriginalAP
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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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