FDA.reportPublic FDA data

Application 214542

Type
ANDA
Sponsor
GENUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDECONCENTRATE;ORAL30MG/MLNoNo
002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDECONCENTRATE;ORAL100MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24338-403Chlorpromazine HydrochlorideChlorpromazine HydrochlorideArbor Pharmaceuticals, LLCANDACurrent
24338-403Chlorpromazine HydrochlorideChlorpromazine HydrochlorideAzurity Pharmaceuticals, Inc.ANDACurrent
24338-410Chlorpromazine HydrochlorideChlorpromazine HydrochlorideArbor Pharmaceuticals, LLCANDACurrent
24338-410Chlorpromazine HydrochlorideChlorpromazine HydrochlorideAzurity Pharmaceuticals, Inc.ANDACurrent
64950-240Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEGenus Lifesciences Inc.ANDACurrent
64950-241Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEGenus Lifesciences Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68083ORIG2021-07-14