← FDA DRUG APPROVALS

FDA NDA · NDA021348

ZAVESCA

miglustat

Sponsor: ACTELION

APPLICATION
NDA021348
TYPE
NDA
ORIGINAL APPROVAL
2003-07-31
LATEST ACTION
2020-12-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ZAVESCA · ReferencePrescription
MIGLUSTAT 100MG · CAPSULE · ORAL

Approval history

2020-12-08Labeling · Supplement 16 · standard — Letter ↗AP
2019-06-26Labeling · Supplement 15 · standard — Letter ↗AP
2016-01-15Manufacturing (CMC) · Supplement 12 · standardAP
2014-10-30Manufacturing (CMC) · Supplement 11 · standardAP
2014-02-10Labeling · Supplement 10 · standard — Label ↗AP
2010-11-23Labeling · Supplement 8 · unknown — Label ↗AP
2008-02-29Labeling · Supplement 5 · standard — Label ↗AP
2003-07-31Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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