Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050748
Company: KING PHARMS
Company: KING PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SYNERCID | DALFOPRISTIN; QUINUPRISTIN | 350MG/VIAL;150MG/VIAL | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
| SYNERCID | DALFOPRISTIN; QUINUPRISTIN | 420MG/VIAL;180MG/VIAL | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/16/2017 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050747s015,050748s014lbl.pdf |
| 01/13/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050747s014,050748s013lbl.pdf | |
| 11/12/2010 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf | |
| 11/12/2010 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf | |
| 06/18/2008 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050748s008,050747s008lbl.pdf | |
| 09/21/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50748lbl.pdf |