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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050748
Company: KING PHARMS

Products on NDA 050748

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050748

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.

Labels for NDA 050748

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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