Home Applications 017555 Application 017555
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SINEMET CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Yes No 002 SINEMET CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Yes Yes 003 SINEMET CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017555-001 SINEMET CARBIDOPA; LEVODOPA 10MG;100MG TABLET / ORAL AB RLD, Approved before 1982 N017555-002 SINEMET CARBIDOPA; LEVODOPA 25MG;250MG TABLET / ORAL AB RLD, Approved before 1982 N017555-003 SINEMET CARBIDOPA; LEVODOPA 25MG;100MG TABLET / ORAL AB RLD, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 4 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-09-29 23:25 UTC 2022-09 N017555-001 SINEMET 10MG;100MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N017555-002 SINEMET 25MG;250MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N017555-003 SINEMET 25MG;100MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017555-001 SINEMET 10MG;100MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017555-002 SINEMET 25MG;250MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017555-003 SINEMET 25MG;100MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017555-001 SINEMET 10MG;100MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017555-002 SINEMET 25MG;250MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017555-003 SINEMET 25MG;100MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-3915 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3915 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3915 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3915 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3916 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3916 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3916 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3916 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3917 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3917 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3917 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-3917 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-6722 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-6722 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-6723 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-6723 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-6724 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 0006-6724 SINEMET carbidopa and levodopa Merck Sharp & Dohme Corp. NDA Current 78206-166 SINEMET carbidopa and levodopa Organon LLC NDA Current 78206-166 SINEMET carbidopa and levodopa Organon LLC NDA Current 78206-167 SINEMET carbidopa and levodopa Organon LLC NDA Current 78206-167 SINEMET carbidopa and levodopa Organon LLC NDA Current 78206-168 SINEMET carbidopa and levodopa Organon LLC NDA Current 78206-168 SINEMET carbidopa and levodopa Organon LLC NDA Current