← FDA DRUG APPROVALS

FDA ANDA · ANDA075139

DYE FREE IBUPROFEN

ibuprofen

Sponsor: LNK

APPLICATION
ANDA075139
TYPE
ANDA
ORIGINAL APPROVAL
1999-03-01
LATEST ACTION
2025-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

IBUPROFENOver-the-counter
IBUPROFEN 200MG · TABLET · ORAL

Approval history

2025-03-20Manufacturing (CMC) · Supplement 18 · unknownAP
2020-07-13Labeling · Supplement 10AP
2005-11-04Supplement · Supplement 8 — Review ↗AP
2004-07-19Supplement · Supplement 7 — Review ↗AP
2003-08-05Supplement · Supplement 5 — Review ↗AP
2003-02-04Supplement · Supplement 6 — Review ↗AP
2002-08-15Labeling · Supplement 4 — Review ↗AP
2002-02-11Manufacturing (CMC) · Supplement 3 — Review ↗AP
2002-02-11Labeling · Supplement 2 — Review ↗AP
2001-08-15Manufacturing (CMC) · Supplement 1 — Review ↗AP
1999-03-01Original — Review ↗AP
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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