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FDA NDA · NDA019771

ADVIL COLD AND SINUS

ibuprofen and pseudoephedrine hydrochloride

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA019771
TYPE
NDA
ORIGINAL APPROVAL
1989-09-19
LATEST ACTION
2021-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

ADVIL COLD AND SINUS · ReferenceOver-the-counter
IBUPROFEN 200MG, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG · TABLET · ORAL

Approval history

2021-11-19Labeling · Supplement 45 · standard — Letter ↗AP
2017-03-23Labeling · Supplement 40 · standard — Letter ↗AP
2010-09-02Labeling · Supplement 36 · unknown — Letter ↗AP
2009-05-19Labeling · Supplement 32 · standard — Letter ↗AP
2008-06-20Labeling · Supplement 31 · standard — Letter ↗AP
2006-04-17Labeling · Supplement 26 · standard — Letter ↗AP
2006-02-23Labeling · Supplement 28 · standard — Letter ↗AP
2003-10-17Labeling · Supplement 22 · standard — Letter ↗AP
2001-08-02Manufacturing (CMC) · Supplement 21 · standardAP
2001-05-23Labeling · Supplement 20 · standard — Label ↗AP
2001-05-14Labeling · Supplement 18 · standardAP
2000-01-18Manufacturing (CMC) · Supplement 17 · standardAP
1999-06-28Manufacturing (CMC) · Supplement 16 · standardAP
1997-01-31Manufacturing (CMC) · Supplement 14 · standardAP
1996-02-01Manufacturing (CMC) · Supplement 13 · standardAP
1994-08-03Manufacturing (CMC) · Supplement 2 · standardAP
1994-06-15Manufacturing (CMC) · Supplement 6 · standardAP
1994-06-13Manufacturing (CMC) · Supplement 9 · standardAP
1994-04-21Manufacturing (CMC) · Supplement 1 · standardAP
1994-03-11Labeling · Supplement 8 · standardAP
1992-05-28Labeling · Supplement 4AP
1991-09-04Labeling · Supplement 7AP
1990-10-17Manufacturing (CMC) · Supplement 3 · standardAP
1989-09-19Type 4 - New Combination · Original · standardAP
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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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