FDA.reportPublic FDA data

Application 078519

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION50MG/5ML (10MG/ML)NoNo
002ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION100MG/10ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-9558ROCURONIUM BROMIDEROCURONIUM BROMIDEHospira, Inc.ANDACurrent
0409-9558Rocuronium BromideRocuronium BromideHospira, Inc.ANDACurrent
0409-9558ROCURONIUM BROMIDEROCURONIUM BROMIDEHospira, Inc.ANDACurrent
0409-9558Rocuronium BromideRocuronium BromideHospira, Inc.ANDACurrent
0409-9558ROCURONIUM BROMIDEROCURONIUM BROMIDEHospira, Inc.ANDACurrent
0409-9558Rocuronium BromideRocuronium BromideHospira, Inc.ANDACurrent
0409-9558Rocuronium BromideRocuronium BromideHospira, Inc.ANDACurrent
0409-9558ROCURONIUM BROMIDEROCURONIUM BROMIDEHospira, Inc.ANDACurrent
51662-1354ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1354ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1354ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1355ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1355ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1355ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
71872-7207Rocuronium BromideRocuronium BromideMedical Purchasing Solutions, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31369ORIG2008-12-02