FDA NDA · NDA020267

JUNIOR STRENGTH ADVIL

ibuprofen

Sponsor: HALEON US HOLDINGS

APPLICATION

NDA020267

TYPE

NDA

ORIGINAL APPROVAL

1996-12-13

LATEST ACTION

2017-03-29

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Over-the-counter

Products

JUNIOR STRENGTH ADVILOver-the-counter

IBUPROFEN 100MG · TABLET · ORAL

2017-03-29Labeling · Supplement 15 · standard — Letter ↗AP

2009-05-19Labeling · Supplement 13 · standard — Letter ↗AP

2008-06-20Labeling · Supplement 12 · standard — Letter ↗AP

2006-01-17Labeling · Supplement 10 · standard — Letter ↗AP

2004-08-30Labeling · Supplement 9 · standard — Review ↗AP

2001-08-02Manufacturing (CMC) · Supplement 6 · standardAP

2000-08-23Labeling · Supplement 5 · standardAP

1999-01-08Manufacturing (CMC) · Supplement 3 · standardAP

1998-10-14Manufacturing (CMC) · Supplement 4 · standardAP

1998-09-30Manufacturing (CMC) · Supplement 2 · standardAP

1998-05-20Manufacturing (CMC) · Supplement 1 · standardAP

1996-12-13Type 3 - New Dosage Form · Original · standardAP

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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