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FDA ANDA · ANDA071265

IBUPROFEN

Sponsor: ADAPTIS

APPLICATION
ANDA071265
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-15
LATEST ACTION
2019-03-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL

Approval history

2019-03-21Labeling · Supplement 48 · standardAP
2019-03-21Labeling · Supplement 46 · standardAP
2019-03-21Labeling · Supplement 49 · standardAP
2006-03-22Labeling · Supplement 27AP
2004-09-29Labeling · Supplement 25AP
1999-12-01Labeling · Supplement 23AP
1996-07-24Manufacturing (CMC) · Supplement 21AP
1996-07-23Manufacturing (CMC) · Supplement 22AP
1994-06-28Manufacturing (CMC) · Supplement 19AP
1993-08-24Manufacturing (CMC) · Supplement 18AP
1991-08-27Manufacturing (CMC) · Supplement 15AP
1991-08-27Manufacturing (CMC) · Supplement 16AP
1990-01-23Bioequivalence · Supplement 17AP
1987-12-18Manufacturing (CMC) · Supplement 13AP
1987-12-18Manufacturing (CMC) · Supplement 11AP
1987-12-18Manufacturing (CMC) · Supplement 12AP
1987-10-02Manufacturing (CMC) · Supplement 10AP
1987-05-14Manufacturing (CMC) · Supplement 1AP
1987-03-06Manufacturing (CMC) · Supplement 2AP
1987-03-06Manufacturing (CMC) · Supplement 9AP
1987-01-21Manufacturing (CMC) · Supplement 5AP
1987-01-21Manufacturing (CMC) · Supplement 3AP
1987-01-21Manufacturing (CMC) · Supplement 8AP
1986-10-15OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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