← FDA DRUG APPROVALS

FDA NDA · NDA021964

RELISTOR

methylnaltrexone bromide

Sponsor: SALIX PHARMS

APPLICATION
NDA021964
TYPE
NDA
ORIGINAL APPROVAL
2008-04-24
LATEST ACTION
2018-03-14
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RELISTOR · ReferencePrescription
METHYLNALTREXONE BROMIDE 12MG/0.6ML (12MG/0.6ML) · SOLUTION · SUBCUTANEOUS
RELISTOR · ReferencePrescription
METHYLNALTREXONE BROMIDE 12MG/0.6ML (12MG/0.6ML) · SOLUTION · SUBCUTANEOUS
RELISTOR · ReferencePrescription
METHYLNALTREXONE BROMIDE 8MG/0.4ML (8MG/0.4ML) · SOLUTION · SUBCUTANEOUS

Approval history

2018-03-14Labeling · Supplement 19 · standard — Label ↗AP
2017-08-01Labeling · Supplement 18 · standard — Label ↗AP
2017-05-16Labeling · Supplement 17 · standard — Label ↗AP
2016-02-05Manufacturing (CMC) · Supplement 16 · standardAP
2015-04-30Manufacturing (CMC) · Supplement 12 · standardAP
2015-02-09Manufacturing (CMC) · Supplement 15 · standardAP
2014-09-29Efficacy · Supplement 10 · standard — Label ↗AP
2013-12-20Manufacturing (CMC) · Supplement 14 · standardAP
2013-08-23Labeling · Supplement 11 · standard — Label ↗AP
2010-09-27Labeling · Supplement 8 · unknownAP
2010-07-23Labeling · Supplement 9 · unknown — Label ↗AP
2009-11-04Labeling · Supplement 6 · standard — Letter ↗AP
2008-04-24Type 1 - New Molecular Entity · Original · standard — Review ↗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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