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FDA NDA · NDA019899

SINE-AID IB

Sponsor: KENVUE BRANDS

APPLICATION
NDA019899
TYPE
NDA
ORIGINAL APPROVAL
1992-12-31
LATEST ACTION
2021-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

SINE-AID IBOver-the-counter
IBUPROFEN 200MG, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG · TABLET · ORAL

Approval history

2021-12-01Labeling · Supplement 20 · standard — Label ↗AP
2017-05-15Labeling · Supplement 19 · standard — Label ↗AP
2006-02-27Labeling · Supplement 18 · standard — Letter ↗AP
2003-07-29Labeling · Supplement 15 · standard — Label ↗AP
2002-09-03Labeling · Supplement 11 · standard — Letter ↗AP
2002-09-03Labeling · Supplement 8 · standard — Letter ↗AP
2002-09-03Labeling · Supplement 12 · standard — Letter ↗AP
2001-05-02Manufacturing (CMC) · Supplement 13 · standardAP
2000-01-06Manufacturing (CMC) · Supplement 9 · standardAP
1999-11-29Manufacturing (CMC) · Supplement 10 · standardAP
1994-06-14Manufacturing (CMC) · Supplement 4 · standardAP
1993-10-13Manufacturing (CMC) · Supplement 1 · standardAP
1993-07-29Manufacturing (CMC) · Supplement 3 · standardAP
1992-12-31Type 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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