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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022522
Company: ASTRAZENECA

Medication Guide

Summary Review

Products on NDA 022522

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DALIRESP	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	AB	Yes	Yes
DALIRESP	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022522

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022522s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022522s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/23/2018	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022522s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022522Orig1s009ltr.pdf
08/31/2017	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022522s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022522Orig1s008ltr.pdf
02/12/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/24/2015	SUPPL-6	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022522s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022522Orig1s006ltr.pdf
09/17/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/23/2013	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022522s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022522Orig1s003ltr.pdf
12/18/2012	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/11/2012	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022522

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/23/2018	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022522s009lbl.pdf
08/31/2017	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022522s008lbl.pdf
11/24/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022522s006lbl.pdf
11/24/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022522s006lbl.pdf
08/23/2013	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022522s003lbl.pdf
02/28/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022522s000lbl.pdf

Therapeutic Equivalents for NDA 022522

DALIRESP

TABLET;ORAL; 500MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DALIRESP	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	Yes	AB	022522	ASTRAZENECA
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	212490	ALKEM LABS LTD
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	213298	AUROBINDO PHARMA LTD
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208213	HETERO LABS LTD III
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208180	MICRO LABS
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208256	MSN
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208257	MYLAN
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208299	PRINSTON INC
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208247	STRIDES PHARMA
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208303	ZYDUS PHARMS

TABLET;ORAL; 250MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DALIRESP	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	Yes	AB	022522	ASTRAZENECA
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	212490	ALKEM LABS LTD
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208213	HETERO LABS LTD III
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208180	MICRO LABS
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208256	MSN
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208247	STRIDES PHARMA
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208272	TORRENT
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208303	ZYDUS PHARMS

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