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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208042
Company: TEVA PHARMS USA

Medication Guide

REMS

Products on NDA 208042

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CASSIPA	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 16MG BASE;EQ 4MG BASE	FILM;SUBLINGUAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208042

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/07/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208042s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208042Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208042Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208042s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208042Orig1s011ltr.pdf
03/20/2024	SUPPL-10	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208042Orig1s010ltr.pdf
03/23/2023	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208042s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208042Orig1s009ltr.pdf
12/16/2022	SUPPL-8	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208042Orig1s008ltr.pdf
06/17/2022	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208042s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208042Orig1s005, s007ltr.pdf
05/03/2022	SUPPL-6	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208042Orig1s006ltr.pdf
06/17/2022	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208042Orig1s005, s007ltr.pdf
03/04/2021	SUPPL-4	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208042s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208042Orig1s004ltr.pdf
10/07/2019	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208042s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208042Orig1s001ltr.pdf

Labels for NDA 208042

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208042s011lbl.pdf
03/23/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208042s009lbl.pdf
06/17/2022	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208042s005s007lbl.pdf
06/17/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208042s005s007lbl.pdf
03/04/2021	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208042s004lbl.pdf
10/07/2019	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208042s001lbl.pdf
10/07/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208042s001lbl.pdf
09/07/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208042s000lbl.pdf

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