FDA.reportPublic FDA data

Application 019627

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPRIVANPROPOFOLINJECTABLE;INJECTION10MG/MLNoNo
002DIPRIVANPROPOFOLINJECTABLE;INJECTION10MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49836-024Anesthesia S/I-60Propofol, Sterile Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-024Anesthesia S/I-60Propofol, Sterile Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-024Anesthesia S/I-60Propofol, Sterile Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-025Anesthesia S/I-40Propofol, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-025Anesthesia S/I-40Propofol, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-025Anesthesia S/I-40Propofol, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
52584-269DiprivanDiprivanGeneral Injectables & Vaccines, IncNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
65219-800DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
65219-800DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
65219-800DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85080SUPPL 2026-02-19
85079SUPPL 2026-02-19
71993SUPPL2022-09-01
71986SUPPL2022-09-01
68284SUPPL2021-08-04
67461SUPPL2021-05-12
48220SUPPL2017-05-02
48192SUPPL2017-05-02
33816SUPPL2014-06-10
11571SUPPL2014-01-28
40941SUPPL2013-09-24
17492SUPPL2013-09-17
40940SUPPL2009-01-12
20269SUPPL2009-01-12
11570SUPPL2008-04-23
17491SUPPL2008-04-16
20268SUPPL2007-07-09
20267SUPPL2007-07-09
23549ORIG2007-06-18
11569SUPPL2007-02-21
17490SUPPL2007-02-12
11568SUPPL2001-02-23
1425SUPPL2001-02-23