Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022235
Company: JAZZ
Company: JAZZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LUVOX | FLUVOXAMINE MALEATE | 25MG | TABLET; ORAL | Prescription | TBD | TBD | No |
LUVOX | FLUVOXAMINE MALEATE | 50MG | TABLET; ORAL | Prescription | TBD | TBD | No |
LUVOX | FLUVOXAMINE MALEATE | 100MG | TABLET; ORAL | Prescription | TBD | TBD | 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 |
---|---|---|---|---|---|---|---|
04/14/2008 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022235lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022235s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022235_luvox_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/22235s000_SumR.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/14/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022235lbl.pdf |
LUVOX
There are no Therapeutic Equivalents.