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FDA NDA · NDA208603

ARYMO ER

Sponsor: ZYLA

APPLICATION
NDA208603
TYPE
NDA
ORIGINAL APPROVAL
2017-01-09
LATEST ACTION
2019-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ARYMO ER · ReferenceDiscontinued
MORPHINE SULFATE 60MG · TABLET, EXTENDED RELEASE · ORAL
ARYMO ER · ReferenceDiscontinued
MORPHINE SULFATE 15MG · TABLET, EXTENDED RELEASE · ORAL
ARYMO ER · ReferenceDiscontinued
MORPHINE SULFATE 30MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-10-07Labeling · Supplement 5 · standard — Letter ↗AP
2018-10-12Efficacy · Supplement 1 · standard — Label ↗AP
2018-09-18REMS · Supplement 3 — Label ↗AP
2018-09-18Labeling · Supplement 4 · standard — Label ↗AP
2017-05-26REMS · Supplement 2 — Letter ↗AP
2017-01-09Type 5 - New Formulation or New Manufacturer · 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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