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FDA NDA · NDA010599

TRAL

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APPLICATION
NDA010599
TYPE
NDA
ORIGINAL APPROVAL
1957-02-13
LATEST ACTION
1988-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRALDiscontinued
HEXOCYCLIUM METHYLSULFATE 25MG · TABLET · ORAL

Approval history

1988-04-14Labeling · Supplement 14AP
1980-10-07Labeling · Supplement 12AP
1980-10-07Labeling · Supplement 10AP
1980-10-07Labeling · Supplement 11AP
1957-02-13Type 1 - New Molecular Entity · Original · standardAP
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