← FDA DRUG APPROVALS

FDA NDA · NDA017555

SINEMET

carbidopa and levodopa

Sponsor: ORGANON

APPLICATION
NDA017555
TYPE
NDA
ORIGINAL APPROVAL
1975-05-02
LATEST ACTION
2026-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SINEMET · ReferencePrescription
CARBIDOPA 25MG, LEVODOPA 250MG · TABLET · ORAL
SINEMET · ReferencePrescription
CARBIDOPA 25MG, LEVODOPA 100MG · TABLET · ORAL
SINEMET · ReferencePrescription
CARBIDOPA 10MG, LEVODOPA 100MG · TABLET · ORAL

Approval history

2026-03-19Labeling · Supplement 76 · standard — Letter ↗AP
2020-03-03Manufacturing (CMC) · Supplement 72 — Label ↗AP
2014-07-17Labeling · Supplement 71 · standard — Label ↗AP
2014-07-17Labeling · Supplement 68 · standard — Letter ↗AP
2014-07-17Labeling · Supplement 56 · standard — Letter ↗AP
2011-02-01Manufacturing (CMC) · Supplement 70 · priority — Label ↗AP
2008-12-31Labeling · Supplement 69 · standard — Review ↗AP
2002-09-05Manufacturing (CMC) · Supplement 62 · priorityAP
2001-10-11Manufacturing (CMC) · Supplement 61 · priorityAP
2001-04-11Labeling · Supplement 38 · priority — Letter ↗AP
2001-04-11Labeling · Supplement 36 · priority — Letter ↗AP
2001-04-11Labeling · Supplement 50 · priority — Letter ↗AP
2001-04-11Labeling · Supplement 40 · priority — Letter ↗AP
2001-04-11Labeling · Supplement 55 · standard — Letter ↗AP
2001-04-11Labeling · Supplement 39 · priority — Letter ↗AP
2001-04-11Labeling · Supplement 45 · priority — Letter ↗AP
2001-04-11Labeling · Supplement 37 · priority — Letter ↗AP
2001-04-11Labeling · Supplement 51 · priority — Letter ↗AP
2001-03-16Manufacturing (CMC) · Supplement 60 · priorityAP
2001-03-16Manufacturing (CMC) · Supplement 57 · priorityAP
2001-02-01Manufacturing (CMC) · Supplement 59 · priorityAP
2001-02-01Manufacturing (CMC) · Supplement 58 · priorityAP
2000-06-06Manufacturing (CMC) · Supplement 54 · priorityAP
2000-04-04Manufacturing (CMC) · Supplement 53 · priorityAP
1997-12-04Manufacturing (CMC) · Supplement 47 · priorityAP
1997-11-26Manufacturing (CMC) · Supplement 48 · priorityAP
1997-11-07Manufacturing (CMC) · Supplement 46 · priorityAP
1996-05-16Manufacturing (CMC) · Supplement 44 · priorityAP
1995-07-13Manufacturing (CMC) · Supplement 43 · priorityAP
1988-04-21Labeling · Supplement 35AP
1988-02-26Manufacturing (CMC) · Supplement 34 · priorityAP
1986-01-17Labeling · Supplement 32AP
1986-01-17Labeling · Supplement 24AP
1986-01-17Labeling · Supplement 33AP
1986-01-17Labeling · Supplement 25AP
1986-01-17Labeling · Supplement 23AP
1985-07-30Labeling · Supplement 30AP
1985-07-12Manufacturing (CMC) · Supplement 31 · priorityAP
1985-05-06Manufacturing (CMC) · Supplement 29 · priorityAP
1984-09-13Manufacturing (CMC) · Supplement 26 · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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