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FDA NDA · NDA021123

ULTRACET

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021123
TYPE
NDA
ORIGINAL APPROVAL
2001-08-15
LATEST ACTION
2023-02-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ULTRACET · ReferenceDiscontinued
ACETAMINOPHEN 325MG, TRAMADOL HYDROCHLORIDE 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-02-13Labeling · Supplement 15 · standard — Letter ↗AP
2021-09-10Labeling · Supplement 21 · standard — Label ↗AP
2021-03-04Labeling · Supplement 20 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 19 · standard — Label ↗AP
2018-09-18Labeling · Supplement 17 · standard — Letter ↗AP
2018-09-18REMS · Supplement 16 — Letter ↗AP
2017-08-29Labeling · Supplement 14 · standard — Label ↗AP
2016-12-16Labeling · Supplement 13 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 12 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 10 · standard — Letter ↗AP
2013-10-18Labeling · Supplement 8 · 901 required — Label ↗AP
2011-06-22Labeling · Supplement 5 · unknown — Letter ↗AP
2009-09-09Labeling · Supplement 3 · standard — Label ↗AP
2004-04-16Labeling · Supplement 1 · standard — Label ↗AP
2001-08-15Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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