Home Applications 018677 Application 018677
Type NDA
Sponsor BAUSCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CESAMET NABILONE CAPSULE;ORAL 1MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018677-001 CESAMET NABILONE 1MG CAPSULE / ORAL RLD 1985-12-26
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N018677-001 CESAMET 1MG CAPSULE / ORAL RLD, RS 1985-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018677-001 CESAMET 1MG CAPSULE / ORAL RLD, RS 1985-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018677-001 CESAMET 1MG CAPSULE / ORAL RLD, RS 1985-12-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018677-001 CESAMET 1MG CAPSULE / ORAL RLD 1985-12-26 a50c72e98297…
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0037-1221 Cesamet Nabilone Meda Pharmaceuticals NDA Current 0037-1221 Cesamet Nabilone Meda Pharmaceuticals Inc. NDA Current 0187-1231 Cesamet Nabilone Bausch Health US LLC NDA Current 0187-1231 Cesamet Nabilone Bausch Health US LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 70950 SUPPL 2022-05-03 70866 SUPPL 2022-05-02 57616 ORIG 2019-02-15 15086 SUPPL 2008-12-10 1018 SUPPL 2006-05-18 33553 SUPPL 2006-05-16