FDA.reportPublic FDA data

Application 050748

Type
NDA
Sponsor
KING PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNERCIDDALFOPRISTIN; QUINUPRISTININJECTABLE;INTRAVENOUS350MG/VIAL;150MG/VIALYesYes
002SYNERCIDDALFOPRISTIN; QUINUPRISTININJECTABLE;INTRAVENOUS420MG/VIAL;180MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48777SUPPL2017-06-20
48754SUPPL2017-06-19
39240SUPPL2012-01-25
30434SUPPL2012-01-18
30433SUPPL2010-11-22
8169SUPPL2010-11-22
39239SUPPL2010-11-17
18166SUPPL2010-11-17
8168SUPPL2008-06-20
18165SUPPL2008-06-19
22215ORIG2001-07-18
30432ORIG1999-09-21
18164ORIG1999-09-21