FDA NDA · NDA016912
LARODOPA
Sponsor: ROCHE
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APPLICATION
NDA016912
TYPE
NDA
ORIGINAL APPROVAL
1970-06-04
LATEST ACTION
1998-08-19
ROUTE
ORAL
DOSAGE FORM
TABLET, CAPSULE
MARKETING STATUS
Discontinued
Products
LARODOPADiscontinued
LEVODOPA 100MG · TABLET · ORAL
LARODOPADiscontinued
LEVODOPA 250MG · TABLET · ORAL
LARODOPADiscontinued
LEVODOPA 250MG · CAPSULE · ORAL
LARODOPADiscontinued
LEVODOPA 500MG · CAPSULE · ORAL
LARODOPADiscontinued
LEVODOPA 500MG · TABLET · ORAL
LARODOPADiscontinued
LEVODOPA 100MG · CAPSULE · ORAL
Approval history
1998-08-19Manufacturing (CMC) · Supplement 48 · priorityAP
1998-05-08Manufacturing (CMC) · Supplement 47 · priorityAP
1997-09-05Manufacturing (CMC) · Supplement 46 · priorityAP
1997-09-03Manufacturing (CMC) · Supplement 45 · priorityAP
1997-05-30Manufacturing (CMC) · Supplement 44 · priorityAP
1993-01-08Manufacturing (CMC) · Supplement 43 · priorityAP
1986-01-03Labeling · Supplement 42 · priorityAP
1983-12-19Manufacturing (CMC) · Supplement 41 · priorityAP
1983-05-17Manufacturing (CMC) · Supplement 40 · priorityAP
1980-08-12Manufacturing (CMC) · Supplement 37 · priorityAP
1980-06-18Manufacturing (CMC) · Supplement 36 · priorityAP
1979-09-13Manufacturing (CMC) · Supplement 35 · priorityAP
1978-03-27Manufacturing (CMC) · Supplement 30 · priorityAP
1977-12-14REMS · Supplement 28 · priorityAP
1977-08-26Manufacturing (CMC) · Supplement 33 · priorityAP
1977-08-05Manufacturing (CMC) · Supplement 34 · priorityAP
1977-05-02Labeling · Supplement 32 · priorityAP
1977-04-29Manufacturing (CMC) · Supplement 31 · priorityAP
1977-01-14Manufacturing (CMC) · Supplement 29 · priorityAP
1975-08-22Manufacturing (CMC) · Supplement 25 · priorityAP
1975-01-06Manufacturing (CMC) · Supplement 23 · priorityAP
1974-11-08Labeling · Supplement 22 · priorityAP
1974-08-02Manufacturing (CMC) · Supplement 19 · priorityAP
1974-08-02Manufacturing (CMC) · Supplement 20 · priorityAP
1970-06-04Type 1 - New Molecular Entity · Original · priorityAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →