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FDA ANDA · ANDA071575

IBUPROFEN

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA071575
TYPE
ANDA
ORIGINAL APPROVAL
1987-05-08
LATEST ACTION
2001-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL

Approval history

2001-06-08Manufacturing (CMC) · Supplement 25AP
2001-06-08Labeling · Supplement 26AP
1998-11-05Manufacturing (CMC) · Supplement 24AP
1997-01-14Manufacturing (CMC) · Supplement 22AP
1996-07-12Manufacturing (CMC) · Supplement 21AP
1996-05-13Manufacturing (CMC) · Supplement 17AP
1994-07-15Manufacturing (CMC) · Supplement 18AP
1989-03-03Manufacturing (CMC) · Supplement 13AP
1989-03-03Manufacturing (CMC) · Supplement 12AP
1989-03-03Manufacturing (CMC) · Supplement 10AP
1988-10-26Bioequivalence · Supplement 16AP
1987-12-15Manufacturing (CMC) · Supplement 9AP
1987-12-15Manufacturing (CMC) · Supplement 8AP
1987-09-09Manufacturing (CMC) · Supplement 5AP
1987-09-09Manufacturing (CMC) · Supplement 6AP
1987-05-08OriginalAP
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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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