← FDA DRUG APPROVALS

FDA NDA · NDA021692

ULTRAM ER

Sponsor: VALEANT PHARMS

APPLICATION
NDA021692
TYPE
NDA
ORIGINAL APPROVAL
2005-09-08
LATEST ACTION
2017-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ULTRAM ER · ReferenceDiscontinued
TRAMADOL HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
ULTRAM ER · ReferenceDiscontinued
TRAMADOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
ULTRAM ER · ReferenceDiscontinued
TRAMADOL HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2017-08-29Labeling · Supplement 15 · standard — Label ↗AP
2016-12-16Labeling · Supplement 14 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 13 · standard — Letter ↗AP
2014-10-27Manufacturing (CMC) · Supplement 12 · standardAP
2009-03-17Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2008-02-20Labeling · Supplement 5 · standard — Label ↗AP
2008-02-20Labeling · Supplement 7 · standard — Label ↗AP
2006-08-03Labeling · Supplement 2 · standard — Letter ↗AP
2006-06-05Labeling · Supplement 1 · standard — Letter ↗AP
2005-09-08Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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