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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021879
Company: AVANIR PHARMS

Summary Review

Products on NDA 021879

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUEDEXTA	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	20MG;10MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021879

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2010	ORIG-1	Approval	Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021879s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021879s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021879Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021879Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2019	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021879s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021879Orig1s014ltr.pdf
01/31/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021879s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021879Orig1s012ltr.pdf
04/21/2017	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
11/18/2016	SUPPL-7	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/021879Orig1s007.pdf
08/14/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/20/2015	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021879s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021879Orig1s005ltr.pdf
11/30/2012	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021879

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2019	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021879s014lbl.pdf
01/31/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021879s012lbl.pdf
01/20/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021879s005lbl.pdf
10/29/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021879s000lbl.pdf

Therapeutic Equivalents for NDA 021879

NUEDEXTA

CAPSULE;ORAL; 20MG;10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	20MG;10MG	CAPSULE;ORAL	Prescription	No	AB	202934	ACTAVIS ELIZABETH
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	20MG;10MG	CAPSULE;ORAL	Prescription	No	AB	218426	HETERO LABS LTD III
NUEDEXTA	DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE	20MG;10MG	CAPSULE;ORAL	Prescription	Yes	AB	021879	AVANIR PHARMS

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