Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 208065
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAGRISSO OSIMERTINIB MESYLATE EQ 40MG BASE TABLET;ORAL Prescription None Yes No
TAGRISSO OSIMERTINIB MESYLATE EQ 80MG BASE TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/13/2015 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208065Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/30/2017 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208065Orig1s006ltr.pdf
09/28/2016 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208065Orig1s003ltr.pdf
08/12/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208065Orig1s002ltr.pdf
02/10/2016 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
03/30/2017 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf
09/28/2016 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s003lbl.pdf
08/12/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s002lbl.pdf
11/13/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English