Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050748
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 Prescription None Yes Yes
SYNERCID DALFOPRISTIN; QUINUPRISTIN 420MG/VIAL;180MG/VIAL INJECTABLE;INTRAVENOUS 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
09/21/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50748lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50747ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50747_Synercid.cfm
Supplements
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)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050748Orig1s014,050747Orig1s015ltr.pdf
01/13/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050747s014,050748s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050747s014,050748s013ltr.pdf
11/12/2010 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,050748s010ltr.pdf
11/12/2010 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,050748s010ltr.pdf
06/18/2008 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050748s008,050747s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050747s008,050748s008ltr.pdf
12/26/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/26/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/24/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/2000 SUPPL-1 Labeling

Label is not available on this site.

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

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