FDA.reportPublic FDA data

Application 065342

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 250MG BASE/VIALNoNo
002CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 500MG BASE/VIALNoNo
003CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 1GM BASE/VIALNoNo
004CEFTRIAXONECEFTRIAXONE SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9856CeftriaxoneCeftriaxoneWest-Ward Pharmaceuticals CorpANDACurrent
0143-9856CeftriaxoneCeftriaxoneHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9857CeftriaxoneCeftriaxoneHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9857CeftriaxoneCeftriaxoneWest-Ward Pharmaceuticals CorpANDACurrent
0143-9858CeftriaxoneCeftriaxoneHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9858CeftriaxoneCeftriaxoneWest-Ward Pharmaceuticals CorpANDACurrent
0143-9859CeftriaxoneceftriaxoneHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9859CeftriaxoneceftriaxoneWest-Ward Pharmaceuticals CorpANDACurrent
50090-2628CeftriaxoneCeftriaxoneA-S Medication SolutionsANDACurrent
50090-2628CeftriaxoneCeftriaxoneA-S Medication SolutionsANDACurrent
55154-7476CeftriaxoneCeftriaxoneCardinal HealthANDACurrent
70518-0384CeftriaxoneCeftriaxoneREMEDYREPACK INC.ANDACurrent
70518-3355CeftriaxoneCeftriaxoneREMEDYREPACK INC.ANDACurrent
72572-061CeftriaxoneCeftriaxoneCivica, Inc.ANDACurrent
72572-061CeftriaxoneCeftriaxoneCivica, Inc.ANDACurrent
72572-061CeftriaxoneCeftriaxoneCivica, Inc.ANDACurrent
72572-062CeftriaxoneCeftriaxoneCivica, Inc.ANDACurrent
72572-062CeftriaxoneCeftriaxoneCivica, Inc.ANDACurrent
72572-062CeftriaxoneCeftriaxoneCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44233ORIG2008-01-17