FDA.reportPublic FDA data

Application 012250

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBOCAINEMEPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION1%YesYes
002CARBOCAINEMEPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION2%YesYes
005CARBOCAINEMEPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION1.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-1036CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1036CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1036CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1036CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1036CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1038CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1038CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1038CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1038CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1038CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1038CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1041CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1041CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1041CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1041CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1041CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1067CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1067CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1067CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1067CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-1067CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-2047CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-2047CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-2047CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-2047CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent
0409-2047CarbocaineMepivacaine HydrochlorideHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77112SUPPL 2023-12-26
77114SUPPL 2023-12-22
56319SUPPL2018-11-06
56258SUPPL2018-11-05
33079SUPPL2010-02-25
314SUPPL2010-02-25
11995SUPPL2005-10-20
10799SUPPL2005-09-30