← FDA DRUG APPROVALS

FDA NDA · NDA020281

ULTRAM

Sponsor: JANSSEN PHARMS

APPLICATION
NDA020281
TYPE
NDA
ORIGINAL APPROVAL
1995-03-03
LATEST ACTION
2023-02-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ULTRAM · ReferenceDiscontinued
TRAMADOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ULTRAM · ReferenceDiscontinued
TRAMADOL HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-02-13Labeling · Supplement 40 · standard — Letter ↗AP
2021-09-10Labeling · Supplement 49 · standard — Label ↗AP
2021-03-04Labeling · Supplement 48 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 45 · standard — Label ↗AP
2019-04-08Labeling · Supplement 41 · standard — Label ↗AP
2018-09-18REMS · Supplement 42 — Letter ↗AP
2018-09-18Labeling · Supplement 43 · standard — Letter ↗AP
2017-08-29Labeling · Supplement 39 · standard — Label ↗AP
2016-12-16Labeling · Supplement 38 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 36 · standard — Letter ↗AP
2009-09-09Labeling · Supplement 33 · standard — Label ↗AP
2009-09-09Labeling · Supplement 32 · standard — Letter ↗AP
2004-04-16Labeling · Supplement 30 · standard — Letter ↗AP
2001-08-15Labeling · Supplement 29 · standard — Label ↗AP
2001-02-13Manufacturing (CMC) · Supplement 28 · standardAP
2000-06-02Manufacturing (CMC) · Supplement 26 · standardAP
2000-04-10Manufacturing (CMC) · Supplement 25 · standardAP
2000-03-21Manufacturing (CMC) · Supplement 20 · standardAP
2000-03-08Manufacturing (CMC) · Supplement 21 · standardAP
1999-12-23Efficacy · Supplement 16 · standard — Letter ↗AP
1999-08-20Manufacturing (CMC) · Supplement 17 · standardAP
1998-08-21Labeling · Supplement 15 · standard — Review ↗AP
1998-08-21Efficacy · Supplement 14 · standard — Review ↗AP
1997-11-20Labeling · Supplement 13 · standardAP
1997-11-20Labeling · Supplement 12 · standardAP
1996-11-27Manufacturing (CMC) · Supplement 9 · standardAP
1996-10-30Manufacturing (CMC) · Supplement 10 · standardAP
1996-03-20Labeling · Supplement 4 · standardAP
1996-03-20Labeling · Supplement 7 · standardAP
1996-03-20Labeling · Supplement 5 · standardAP
1996-03-20Labeling · Supplement 8 · standardAP
1996-03-20Labeling · Supplement 6 · standardAP
1995-12-22Manufacturing (CMC) · Supplement 2 · standardAP
1995-12-22Manufacturing (CMC) · Supplement 3 · standardAP
1995-10-20Manufacturing (CMC) · Supplement 1 · standardAP
1995-03-03Type 1 - New Molecular Entity · 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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