← FDA DRUG APPROVALS

FDA NDA · NDA019872

TYLENOL 8 HR ARTHRITIS PAIN

acetaminophen

Sponsor: KENVUE BRANDS

APPLICATION
NDA019872
TYPE
NDA
ORIGINAL APPROVAL
1994-06-08
LATEST ACTION
2019-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

TYLENOL · ReferenceOver-the-counter
ACETAMINOPHEN 650MG · TABLET, EXTENDED RELEASE · ORAL
TYLENOL · ReferenceOver-the-counter
ACETAMINOPHEN 650MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-01-16Labeling · Supplement 48 · standard — Letter ↗AP
2016-08-26Labeling · Supplement 44 · standard — Label ↗AP
2016-05-05Manufacturing (CMC) · Supplement 43 · standardAP
2014-12-23Labeling · Supplement 42 · standard — Letter ↗AP
2014-12-12Labeling · Supplement 41 · standard — Label ↗AP
2014-03-06Labeling · Supplement 40 · standard — Label ↗AP
2013-12-20Labeling · Supplement 39 · standard — Label ↗AP
2013-03-28Manufacturing (CMC) · Supplement 38 · standardAP
2013-03-26Labeling · Supplement 37 · standard — Letter ↗AP
2011-12-23Labeling · Supplement 36 · standard — Letter ↗AP
2010-05-10Manufacturing (CMC) · Supplement 34 · standard — Letter ↗AP
2010-05-06Labeling · Supplement 33 · standard — Letter ↗AP
2009-09-18Manufacturing (CMC) · Supplement 32AP
2009-06-17Labeling · Supplement 31 · standard — Label ↗AP
2008-02-28Labeling · Supplement 29 · standard — Review ↗AP
2004-11-03Manufacturing (CMC) · Supplement 21 · standard — Letter ↗AP
2004-04-13Labeling · Supplement 18 · standard — Letter ↗AP
2004-03-22Manufacturing (CMC) · Supplement 17 · standard — Letter ↗AP
2003-08-01Manufacturing (CMC) · Supplement 16 · standard — Letter ↗AP
2003-05-29Labeling · Supplement 12 · standard — Label ↗AP
2003-05-28Labeling · Supplement 14 · standard — Letter ↗AP
2003-05-28Labeling · Supplement 13 · standard — Letter ↗AP
2001-02-12Manufacturing (CMC) · Supplement 11 · standardAP
2001-01-11Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
2000-07-25Manufacturing (CMC) · Supplement 10 · standardAP
2000-07-25Labeling · Supplement 9 · standard — Review ↗AP
1995-08-01Manufacturing (CMC) · Supplement 5 · standardAP
1995-07-28Manufacturing (CMC) · Supplement 2 · standardAP
1995-01-05Manufacturing (CMC) · Supplement 3 · standardAP
1994-11-23Manufacturing (CMC) · Supplement 1 · standardAP
1994-06-08Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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