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FDA ANDA · ANDA071229

IBUPROFEN

Sponsor: PH HEALTH

APPLICATION
ANDA071229
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-01
LATEST ACTION
1997-12-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL

Approval history

1997-12-05Manufacturing (CMC) · Supplement 12AP
1997-02-24Manufacturing (CMC) · Supplement 11AP
1995-06-22Manufacturing (CMC) · Supplement 10AP
1994-01-12Manufacturing (CMC) · Supplement 9AP
1992-12-14Manufacturing (CMC) · Supplement 8AP
1989-01-13Manufacturing (CMC) · Supplement 3AP
1989-01-13Manufacturing (CMC) · Supplement 6AP
1988-06-17Manufacturing (CMC) · Supplement 5AP
1987-08-27Manufacturing (CMC) · Supplement 2AP
1987-07-17Manufacturing (CMC) · Supplement 1AP
1987-04-01OriginalAP
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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