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FDA NDA · NDA203496

ORENITRAM

treprostinil

Sponsor: UNITED THERAP

APPLICATION
NDA203496
TYPE
NDA
ORIGINAL APPROVAL
2013-12-20
LATEST ACTION
2020-11-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ORENITRAM · ReferencePrescription
TREPROSTINIL DIOLAMINE EQ 5MG BASE · TABLET, EXTENDED RELEASE · ORAL
ORENITRAM · ReferencePrescription
TREPROSTINIL DIOLAMINE EQ 1MG BASE · TABLET, EXTENDED RELEASE · ORAL
ORENITRAM · ReferencePrescription
TREPROSTINIL DIOLAMINE EQ 0.125MG BASE · TABLET, EXTENDED RELEASE · ORAL
ORENITRAM · ReferencePrescription
TREPROSTINIL DIOLAMINE EQ 2.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
ORENITRAM · ReferencePrescription
TREPROSTINIL DIOLAMINE EQ 0.25MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2020-11-03Manufacturing (CMC) · Supplement 13 · standard — Label ↗AP
2019-10-18Efficacy · Supplement 11 · standard — Label ↗AP
2017-06-07Labeling · Supplement 7 · standard — Label ↗AP
2017-01-24Labeling · Supplement 6 · standard — Label ↗AP
2016-01-28Efficacy · Supplement 2 · standard — Label ↗AP
2014-10-06Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2013-12-20Type 3 - New Dosage Form · Original · standard — Label ↗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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