← FDA DRUG APPROVALS

FDA NDA · NDA205777

TARGINIQ

Sponsor: PURDUE PHARMA LP

APPLICATION
NDA205777
TYPE
NDA
ORIGINAL APPROVAL
2014-07-23
LATEST ACTION
2018-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

TARGINIQ · ReferenceDiscontinued
NALOXONE HYDROCHLORIDE 10MG, OXYCODONE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL
TARGINIQ · ReferenceDiscontinued
NALOXONE HYDROCHLORIDE 20MG, OXYCODONE HYDROCHLORIDE 40MG · TABLET, EXTENDED RELEASE · ORAL
TARGINIQ · ReferenceDiscontinued
NALOXONE HYDROCHLORIDE 5MG, OXYCODONE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-09-18REMS · Supplement 10 — Label ↗AP
2018-09-18Labeling · Supplement 11 · standard — Label ↗AP
2017-05-26REMS · Supplement 7 — Letter ↗AP
2016-12-16Labeling · Supplement 4 · standard — Label ↗AP
2016-09-30REMS · Supplement 5 — Letter ↗AP
2016-04-20REMS · Supplement 3 — Letter ↗AP
2015-06-26REMS · Supplement 2 — Letter ↗AP
2014-08-19REMS · Supplement 1 — Letter ↗AP
2014-07-23Type 4 - New Combination · Original · standard — Other ↗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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