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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018677
Company: BAUSCH

Products on NDA 018677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CESAMET	NABILONE	1MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/1985	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018677Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2022	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018677Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018677Orig1s017ltr.pdf
03/30/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/05/2008	SUPPL-13	Manufacturing (CMC)-Formulation	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018677s013ltr.pdf
05/15/2006	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018677s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018677s011LTR.pdf
06/23/1989	SUPPL-6	Labeling		Label is not available on this site.
04/11/1989	SUPPL-5	Labeling		Label is not available on this site.
03/18/1988	SUPPL-4	Labeling		Label is not available on this site.
11/30/1987	SUPPL-3	Labeling		Label is not available on this site.
12/04/1986	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/1986	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018677

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2022	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018677Orig1s017lbl.pdf
04/28/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018677Orig1s017lbl.pdf
05/15/2006	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018677s011lbl.pdf

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