FDA.reportPublic FDA data

Application 207594

Type
ANDA
Sponsor
HQ SPCLT PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-705Imipenem and CilastatinImipenem and CilastatinWG Critical Care, LLCANDACurrent
44567-705Imipenem and CilastatinImipenem and CilastatinWG Critical Care, LLCANDACurrent