Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021504
Company: VYTERIS
Company: VYTERIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOSITE TOPICAL SYSTEM KIT | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 1.05MG/PATCH;100MG/PATCH | PATCH;IONTOPHORESIS, TOPICAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
05/06/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21504_lidoSite_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21504ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021504s000_LidositeTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/15/2005 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021504s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/06/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21504_lidoSite_lbl.pdf |