Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022509
Company: SMITHKLINE BEECHAM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMICTAL XR LAMOTRIGINE 25MG TABLET, EXTENDED RELEASE; ORAL Prescription None No No
LAMICTAL XR LAMOTRIGINE 50MG TABLET, EXTENDED RELEASE; ORAL Prescription None No No
LAMICTAL XR LAMOTRIGINE 100MG TABLET, EXTENDED RELEASE; ORAL Prescription None No No
LAMICTAL XR LAMOTRIGINE 200MG TABLET, EXTENDED RELEASE; ORAL Prescription None No 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
01/29/2010 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/2010/022509lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022509s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022509_lamictal_xr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022509Orig1s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/29/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022509lbl.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