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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022165
Company: ASSERTIO

Medication Guide

Summary Review

Products on NDA 022165

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAMBIA	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022165

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2009	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022165lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022165s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022165s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022165Orig1s016ltr.pdf
04/28/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022165Orig1s013,s014ltr.pdf
04/28/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022165Orig1s013,s014ltr.pdf
03/20/2017	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022165Orig1s012ltr.pdf
05/09/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022165s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022165Orig1s011ltr.pdf
12/10/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/30/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/23/2024	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022165Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022165Orig1s006ltr.pdf
07/20/2011	SUPPL-4	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022165s004ltr.pdf

Labels for NDA 022165

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022165s016lbl.pdf
04/23/2024	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022165Orig1s006lbl.pdf
04/28/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf
04/28/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf
03/20/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf
05/09/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022165s011lbl.pdf
06/17/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022165lbl.pdf

Therapeutic Equivalents for NDA 022165

CAMBIA

FOR SOLUTION;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAMBIA	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	Yes	AB	022165	ASSERTIO
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	216635	ALKEM LABS LTD
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	215375	ANNORA PHARMA
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	202964	ENDO OPERATIONS
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	218011	TARO

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