APPLICATION
NDA019856
TYPE
NDA
ORIGINAL APPROVAL
1991-05-30
LATEST ACTION
2026-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
SINEMET CR · ReferenceDiscontinued
CARBIDOPA 25MG, LEVODOPA 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SINEMET CR · ReferenceDiscontinued
CARBIDOPA 50MG, LEVODOPA 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
Approval history
2002-09-05Manufacturing (CMC) · Supplement 20 · standardAP
2001-10-11Manufacturing (CMC) · Supplement 19 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 18 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 17 · standardAP
2000-06-06Manufacturing (CMC) · Supplement 14 · standardAP
2000-05-02Labeling · Supplement 15 · standardAP
1999-08-04Manufacturing (CMC) · Supplement 11 · standardAP
1999-05-10Labeling · Supplement 9 · standardAP
1999-05-10Labeling · Supplement 7 · standardAP
1999-05-10Labeling · Supplement 1AP
1999-05-10Labeling · Supplement 12 · standardAP
1999-05-10Labeling · Supplement 6 · standardAP
1998-06-10Manufacturing (CMC) · Supplement 10 · standardAP
1996-05-16Manufacturing (CMC) · Supplement 4 · standardAP
1996-05-07Manufacturing (CMC) · Supplement 5 · standardAP
1993-10-07Manufacturing (CMC) · Supplement 3 · standardAP
1992-12-24Manufacturing (CMC) · Supplement 2 · standardAP
1991-05-30Type 3 - New Dosage Form · 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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