FDA.reportPublic FDA data

Application 018304

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SENSORCAINEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.25%NoNo
002SENSORCAINEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%NoNo
003SENSORCAINEBUPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION0.75%NoNo
004SENSORCAINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.5%;0.0091MG/MLNoNo
005SENSORCAINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.75%;0.0091MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9945SensorcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9945SensorcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9947SensorcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9947SensorcaineBupivacaine HydrochlorideHenry Schein, Inc.NDACurrent
51662-1588BUPIVACAINE HClBUPIVACAINE HClHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1588BUPIVACAINE HClBUPIVACAINE HClHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1592BUPIVACAINE HClBUPIVACAINE HClHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-465SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-465SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-465SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-465SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-465SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-465SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-467SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-467SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-467SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-467SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-467SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-467SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-467SensorcaineBupivacaine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
63323-460SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCNDACurrent
63323-460SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCNDACurrent
63323-460SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCNDACurrent
63323-462SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCNDACurrent
63323-462SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCNDACurrent
63323-462SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCNDACurrent
63323-464SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-464SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-464SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-465SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-465SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-465SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-466SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-466SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-466SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-467SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-467SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
63323-467SENSORCAINEBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDACurrent
70518-1392SENSORCAINEBUPIVACAINE HYDROCHLORIDEREMEDYREPACK INC.NDACurrent
70518-2657SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71616SUPPL2022-07-21
71608SUPPL2022-07-20
56325SUPPL2018-11-07
56261SUPPL2018-11-05
14977SUPPL2015-07-14
897SUPPL2015-07-14
33474SUPPL2015-07-13
11202SUPPL2015-07-13