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FDA NDA · NDA207621

TROXYCA ER

Sponsor: PFIZER

APPLICATION
NDA207621
TYPE
NDA
ORIGINAL APPROVAL
2016-08-19
LATEST ACTION
2017-05-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

TROXYCA ERDiscontinued
NALTREXONE HYDROCHLORIDE 9.6MG, OXYCODONE HYDROCHLORIDE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
TROXYCA ERDiscontinued
NALTREXONE HYDROCHLORIDE 4.8MG, OXYCODONE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
TROXYCA ERDiscontinued
NALTREXONE HYDROCHLORIDE 2.4MG, OXYCODONE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
TROXYCA ERDiscontinued
NALTREXONE HYDROCHLORIDE 7.2MG, OXYCODONE HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
TROXYCA ERDiscontinued
NALTREXONE HYDROCHLORIDE 3.6MG, OXYCODONE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
TROXYCA ERDiscontinued
NALTREXONE HYDROCHLORIDE 1.2MG, OXYCODONE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2017-05-26REMS · Supplement 5 — Letter ↗AP
2016-12-16Labeling · Supplement 4 · standard — Label ↗AP
2016-09-30REMS · Supplement 1 — Letter ↗AP
2016-08-19Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — 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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