An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	208236	BRECKENRIDGE
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	208303	ZYDUS PHARMS

Top