← FDA DRUG APPROVALS

FDA NDA · NDA021272

REMODULIN

treprostinil

Sponsor: UNITED THERAP

APPLICATION
NDA021272
TYPE
NDA
ORIGINAL APPROVAL
2002-05-21
LATEST ACTION
2023-03-07
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

REMODULIN · ReferenceDiscontinued
TREPROSTINIL 0.2MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
REMODULIN · ReferenceDiscontinued
TREPROSTINIL 20MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
REMODULIN · ReferencePrescription
TREPROSTINIL 5MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
REMODULIN · ReferencePrescription
TREPROSTINIL 1MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
REMODULIN · ReferencePrescription
TREPROSTINIL 0.4MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
REMODULIN · ReferenceDiscontinued
TREPROSTINIL 0.1MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
REMODULIN · ReferencePrescription
TREPROSTINIL 10MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
REMODULIN · ReferencePrescription
TREPROSTINIL 2.5MG/ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS

Approval history

2023-03-07Labeling · Supplement 37 · standard — Letter ↗AP
2021-07-30Manufacturing (CMC) · Supplement 32 — Letter ↗AP
2020-08-19Manufacturing (CMC) · Supplement 30 — Letter ↗TA
2018-07-30Labeling · Supplement 25 · standard — Label ↗AP
2018-06-08Labeling · Supplement 26 · standard — Label ↗AP
2016-01-22Manufacturing (CMC) · Supplement 22 · priorityAP
2014-12-22Manufacturing (CMC) · Supplement 19 — Label ↗AP
2014-01-03Manufacturing (CMC) · Supplement 21 · priorityAP
2013-09-26Labeling · Supplement 20 · standard — Review ↗AP
2011-02-08Labeling · Supplement 15 · unknown — Letter ↗AP
2010-01-08Labeling · Supplement 11 · standard — Letter ↗AP
2008-09-12Labeling · Supplement 8 · standard — Label ↗AP
2008-02-04Labeling · Supplement 9 · standard — Letter ↗AP
2006-03-20Efficacy · Supplement 5 · priority — Label ↗AP
2006-01-20Labeling · Supplement 3 · standard — Letter ↗AP
2004-11-24Efficacy · Supplement 2 · standard — Review ↗AP
2002-05-21Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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