← FDA DRUG APPROVALS

FDA NDA · NDA017871

DEMSER

metyrosine

Sponsor: BAUSCH

APPLICATION
NDA017871
TYPE
NDA
ORIGINAL APPROVAL
1979-10-03
LATEST ACTION
2014-07-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DEMSER · ReferencePrescription
METYROSINE 250MG · CAPSULE · ORAL

Approval history

2014-07-15Manufacturing (CMC) · Supplement 19 · priorityAP
2013-11-08Manufacturing (CMC) · Supplement 18 · priorityAP
2003-05-30Labeling · Supplement 11 · standard — Letter ↗AP
2001-12-12Manufacturing (CMC) · Supplement 10 · priorityAP
1994-03-16Manufacturing (CMC) · Supplement 9 · priorityAP
1988-07-07Manufacturing (CMC) · Supplement 7 · priorityAP
1987-12-23Manufacturing (CMC) · Supplement 8 · priorityAP
1985-11-01Labeling · Supplement 6AP
1985-09-06Labeling · Supplement 5AP
1984-01-25Manufacturing (CMC) · Supplement 4 · priorityAP
1980-11-14Manufacturing (CMC) · Supplement 3 · priorityAP
1979-10-03Type 1 - New Molecular Entity · Original · priorityAP
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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