FDA.reportPublic FDA data

Application 205883

Type
ANDA
Sponsor
AMNEAL PHARMS

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
68001-323MeropenemMeropenemBluePoint LaboratoriesANDACurrent
68001-323MeropenemMeropenemBluePoint LaboratoriesANDACurrent
68001-323MeropenemMeropenemBluePoint LaboratoriesANDACurrent
68001-324MeropenemMeropenemBluePoint LaboratoriesANDACurrent
68001-324MeropenemMeropenemBluePoint LaboratoriesANDACurrent
68001-324MeropenemMeropenemBluePoint LaboratoriesANDACurrent
70121-1453MeropenemMeropenemAmneal Pharmaceuticals LLCANDACurrent
70121-1453MeropenemMeropenemAmneal Biosciences LLCANDACurrent
70121-1453MeropenemMeropenemAmneal Biosciences LLCANDACurrent
70121-1453MeropenemMeropenemAmneal Pharmaceuticals LLCANDACurrent
70121-1453MeropenemMeropenemAmneal Pharmaceuticals LLCANDACurrent
70121-1454MeropenemMeropenemAmneal Pharmaceuticals LLCANDACurrent
70121-1454MeropenemMeropenemAmneal Biosciences LLCANDACurrent
70121-1454MeropenemMeropenemAmneal Biosciences LLCANDACurrent
70121-1454MeropenemMeropenemAmneal Pharmaceuticals LLCANDACurrent
70121-1454MeropenemMeropenemAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32762ORIG2016-04-14
19697ORIG2016-04-14