Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 204734
Company: SHIRE DEV LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSRENOL LANTHANUM CARBONATE EQ 750MG BASE POWDER;ORAL Prescription None Yes No
FOSRENOL LANTHANUM CARBONATE EQ 1GM BASE POWDER;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
09/24/2014 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021468Orig1s020,204734Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204734Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204734Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2018 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021468Orig1s021,204734Orig1s003ltr.pdf
02/24/2016 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204734s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204734Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/08/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf
02/24/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204734s000lbl.pdf
09/24/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.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