FDA.reportPublic FDA data

Application 210773

Type
ANDA
Sponsor
HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEROPENEMMEROPENEMINJECTABLE;INJECTION500MG/VIALNoNo
002MEROPENEMMEROPENEMINJECTABLE;INJECTION1GM/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-145MeropenemMeropenemWG Critical Care, LLCANDACurrent
44567-145MeropenemMeropenemWG Critical Care, LLCANDACurrent
44567-146MeropenemMeropenemWG Critical Care, LLCANDACurrent
44567-146MeropenemMeropenemWG Critical Care, LLCANDACurrent
44567-400MeropenemMeropenemWG Critical Care, LLCANDACurrent
44567-400MeropenemMeropenemWG Critical Care, LLCANDACurrent
44567-401MeropenemMeropenemWG Critical Care, LLCANDACurrent
44567-401MeropenemMeropenemWG Critical Care, LLCANDACurrent