FDA.report

Application 016964

Type
NDA
Sponsor
HOSPIRA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%YesYes
004MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.25%;0.0091MG/MLYesYes
005MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%YesYes
006MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%YesYes
007MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.5%;0.0091MG/MLYesYes
008MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.5%;0.0091MG/MLYesYes
009MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.75%YesYes
010MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.75%;0.0091MG/MLYesYes
012MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%YesYes
013MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.25%;0.0091MG/MLYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9906MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9906MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9907MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9907MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9907MarcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9908MARCAINE WITH EPINEPHRINEbupivacaine hydrochloride and epinephrine bitartrateHenry Schein, Inc.NDACurrent
0404-9908MARCAINE WITH EPINEPHRINEbupivacaine hydrochloride and epinephrine bitartrateHenry Schein, Inc.NDACurrent
0409-1541Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.NDACurrent
0409-1541Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1559MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1560MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1582MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1587MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1610MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1746Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1749Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1752Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent
0409-1755Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDACurrent

Documents

DocumentSubmission typeDate
64445SUPPL2020-08-28
64375SUPPL2020-08-24
56320SUPPL2018-11-06
56259SUPPL2018-11-05
519SUPPL2012-02-01
10943SUPPL2012-01-30
10942SUPPL2010-02-25
518SUPPL2010-02-25
13062SUPPL2005-11-01
10941SUPPL2005-11-01