Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022522
Company: ASTRAZENECA PHARMS
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 None Yes No
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.

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

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 PHARMS
ROFLUMILAST ROFLUMILAST 500MCG TABLET;ORAL Prescription No AB 208236 BRECKENRIDGE
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 208272 TORRENT

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