Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 202324
Company: PF PRISM CV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INLYTA AXITINIB 1MG TABLET;ORAL Prescription None Yes No
INLYTA AXITINIB 5MG 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
01/27/2012 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/2012/202324lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202324s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202324Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202324Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2018 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202324s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202324Orig1s008ltr.pdf
06/16/2016 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/30/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/29/2014 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s003ltr.pdf
08/01/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s002ltr.pdf
09/16/2013 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202324s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202324Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/10/2018 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202324s008lbl.pdf
12/29/2014 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324Orig1s003lbl.pdf
08/01/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324s002lbl.pdf
09/16/2013 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202324s001lbl.pdf
01/27/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202324lbl.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