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FDA NDA · NDA203202

NORTHERA

droxidopa

Sponsor: LUNDBECK NA LTD

APPLICATION
NDA203202
TYPE
NDA
ORIGINAL APPROVAL
2014-02-18
LATEST ACTION
2017-02-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

NORTHERA · ReferencePrescription
DROXIDOPA 200MG · CAPSULE · ORAL
NORTHERA · ReferencePrescription
DROXIDOPA 300MG · CAPSULE · ORAL
NORTHERA · ReferencePrescription
DROXIDOPA 100MG · CAPSULE · ORAL

Approval history

2017-02-10Labeling · Supplement 7 · standard — Label ↗AP
2016-10-03Labeling · Supplement 6 · standard — Letter ↗AP
2015-08-24Manufacturing (CMC) · Supplement 5 · priorityAP
2015-08-19Manufacturing (CMC) · Supplement 4 · priorityAP
2014-11-03Manufacturing (CMC) · Supplement 3 · priorityAP
2014-11-03Manufacturing (CMC) · Supplement 1 · priorityAP
2014-09-30Manufacturing (CMC) · Supplement 2 · priorityAP
2014-02-18Type 1 - New Molecular Entity · Original · priority — Label ↗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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