FDA.reportPublic FDA data

Application 018461

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION100MG/100MLNoNo
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
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
51662-1302LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1302LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1302LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47243SUPPL2017-02-16
47133SUPPL2017-02-08
15010SUPPL2012-03-12
33493SUPPL2012-03-05
15009SUPPL2012-02-29
926SUPPL2003-12-16
40800SUPPL2002-09-10
15008SUPPL2002-01-23
11223SUPPL2002-01-23