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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022198
Company: CUMBERLAND

Products on NDA 022198

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SANCUSO	GRANISETRON	3.1MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022198

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2008	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022198lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022198s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022198_sancuso_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2020	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022198s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022198Orig1s020ltr.pdf
12/06/2022	SUPPL-19	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/22198Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022198Orig1s019ltr.pdf
09/13/2017	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022198s016lbl.pdf
09/18/2014	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022198s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022198Orig1s012ltr.pdf
07/15/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/19/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/14/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/23/2011	SUPPL-5	Labeling, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022198s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022198s005ltr.pdf
09/28/2015	SUPPL-3	Labeling, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022198s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022198Orig1s003ltr.pdf

Labels for NDA 022198

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2022	SUPPL-19	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/22198Orig1s019lbl.pdf
04/30/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022198s020lbl.pdf
09/13/2017	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022198s016lbl.pdf
09/28/2015	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022198s003lbl.pdf
09/28/2015	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022198s003lbl.pdf
09/18/2014	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022198s012lbl.pdf
09/23/2011	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022198s005lbl.pdf
09/23/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022198s005lbl.pdf
09/12/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022198lbl.pdf

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