Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016023
Company: ENDO PHARMS
Company: ENDO PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYMMETREL | AMANTADINE HYDROCHLORIDE | 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/02/2009 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.pdf | |
| 09/24/2008 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf | |
| 03/02/2007 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf | |
| 11/18/2003 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf |