FDA NDA · NDA020602

JUNIOR STRENGTH MOTRIN

Sponsor: KENVUE BRANDS

APPLICATION

NDA020602

TYPE

NDA

ORIGINAL APPROVAL

1996-06-10

LATEST ACTION

2017-05-15

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Over-the-counter

Products

JUNIOR STRENGTH MOTRINOver-the-counter

IBUPROFEN 100MG · TABLET · ORAL

2017-05-15Labeling · Supplement 13 · standard — Label ↗AP

2010-10-13Labeling · Supplement 10 · unknown — Letter ↗AP

2009-04-27Labeling · Supplement 9 · standard — Letter ↗AP

2006-02-27Labeling · Supplement 8 · standard — Letter ↗AP

2001-05-02Manufacturing (CMC) · Supplement 4 · standardAP

1999-09-13Labeling · Supplement 3 · standard — Review ↗AP

1998-06-12Labeling · Supplement 1 · standardAP

1998-06-12Labeling · Supplement 2 · standardAP

1996-06-10Type 8 - Partial Rx to OTC Switch · 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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