Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022509
Company: SMITHKLINE BEECHAM
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 |