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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022202
Company: ASSERTIO

Medication Guide

Summary Review

Products on NDA 022202

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIPSOR	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022202

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2009	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/2009/022202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022202s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022202_zipsor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022202s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022202s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022202Orig1s013,s014ltr.pdf
05/25/2021	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022202s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022202Orig1s013,s014ltr.pdf
05/09/2016	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022202Orig1s011ltr.pdf
12/16/2015	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
08/07/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/04/2011	SUPPL-4	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022202s003,s004ltr.pdf
05/04/2011	SUPPL-3	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022202s003s,s004ltr.pdf

Labels for NDA 022202

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022202s013s014lbl.pdf
05/25/2021	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022202s013s014lbl.pdf
05/09/2016	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf
05/09/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf
05/09/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf
06/16/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022202lbl.pdf

Therapeutic Equivalents for NDA 022202

ZIPSOR

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	No	AB	213875	AUROBINDO PHARMA LTD
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	No	AB	204648	BIONPHARMA
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	No	AB	210078	STRIDES PHARMA
ZIPSOR	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	Yes	AB	022202	ASSERTIO

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