Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021412
Company: BIOVAIL LABS INTL
Company: BIOVAIL LABS INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOVALT ODT | ZOLPIDEM TARTRATE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
TOVALT ODT | ZOLPIDEM TARTRATE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
04/25/2007 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021412lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021412s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021412TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021412_tovalt_odt_toc.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/25/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021412lbl.pdf |