APPLICATION
NDA016913
TYPE
NDA
ORIGINAL APPROVAL
1970-06-04
LATEST ACTION
1992-05-05
ROUTE
ORAL
DOSAGE FORM
TABLET, CAPSULE
MARKETING STATUS
Discontinued
Products
DOPARDiscontinued
LEVODOPA 500MG · TABLET · ORAL
DOPARDiscontinued
LEVODOPA 100MG · CAPSULE · ORAL
DOPARDiscontinued
LEVODOPA 250MG · CAPSULE · ORAL
DOPARDiscontinued
LEVODOPA 250MG · TABLET · ORAL
DOPARDiscontinued
LEVODOPA 500MG · CAPSULE · ORAL
Approval history
1992-05-05Manufacturing (CMC) · Supplement 31 · standardAP
1989-12-29Manufacturing (CMC) · Supplement 30 · standardAP
1986-05-23Manufacturing (CMC) · Supplement 29 · standardAP
1983-03-30Manufacturing (CMC) · Supplement 28 · standardAP
1983-03-30Manufacturing (CMC) · Supplement 26 · standardAP
1983-03-30Manufacturing (CMC) · Supplement 24 · standardAP
1983-03-30Manufacturing (CMC) · Supplement 27 · standardAP
1983-03-30Manufacturing (CMC) · Supplement 25 · standardAP
1977-08-22Manufacturing (CMC) · Supplement 20 · standardAP
1977-04-14Manufacturing (CMC) · Supplement 19 · standardAP
1976-07-30Manufacturing (CMC) · Supplement 18 · standardAP
1975-02-27Manufacturing (CMC) · Supplement 17 · standardAP
1975-02-27Efficacy · Supplement 15AP
1970-06-04Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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