FDA.reportPublic FDA data

Application 019830

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION200MG/100MLNoNo
003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION400MG/100MLNoNo
004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION800MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-9594Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEB. Braun Medical Inc.NDACurrent
0264-9594Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEB. Braun Medical Inc.NDACurrent
0264-9598Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEB. Braun Medical Inc.NDACurrent
0264-9598Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEB. Braun Medical Inc.NDACurrent
50090-4555Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEA-S Medication SolutionsNDACurrent
50090-4559Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEA-S Medication SolutionsNDACurrent
51662-1565LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63164SUPPL2020-05-20
63154SUPPL2020-05-20
33996SUPPL2013-02-06
1658SUPPL2013-02-04
19271SUPPL2004-06-25