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 42.

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD	1985-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018677-001	CESAMET	1MG	CAPSULE / ORAL	RLD, RS	1985-12-26	`3a93d1ddd44b…`
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…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cesamet	NABILONE	Bausch Health US LLC	83c7ac15-ece9-47de-b83c-d575544fa449	2021-01-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018677 application number: NDA018677 ndc (product): 0187-1231

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