Application 090825

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAVENOUSEQ 250MG BASE/VIAL;250MG/VIALNoNo
002IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAVENOUSEQ 500MG BASE/VIAL;500MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-3507Imipenem and CilastatinImipenem and CilastatinHospira, Inc.ANDACurrent
0409-3508Imipenem and CilastatinImipenem and CilastatinHospira, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31501ORIG2011-11-21