FDA.reportPublic FDA data

Application 212630

Type
ANDA
Sponsor
ENALTEC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo
004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL100MGNoNo
005CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62135-420chlorpromazine hydrochloridechlorpromazine hydrochlorideChartwell RX, LLCANDACurrent
62135-421chlorpromazine hydrochloridechlorpromazine hydrochlorideChartwell RX, LLCANDACurrent
62135-422chlorpromazine hydrochloridechlorpromazine hydrochlorideChartwell RX, LLCANDACurrent
62135-423chlorpromazine hydrochloridechlorpromazine hydrochlorideChartwell RX, LLCANDACurrent
62135-424chlorpromazine hydrochloridechlorpromazine hydrochlorideChartwell RX, LLCANDACurrent
90096-131ChlorproMAZINE HydrochlorideChlorproMAZINE HydrochlorideZameer Pharmaceuticals LLCANDACurrent
90096-132ChlorproMAZINE HydrochlorideChlorproMAZINE HydrochlorideZameer Pharmaceuticals LLCANDACurrent
90096-133ChlorproMAZINE HydrochlorideChlorproMAZINE HydrochlorideZameer Pharmaceuticals LLCANDACurrent
90096-134ChlorproMAZINE HydrochlorideChlorproMAZINE HydrochlorideZameer Pharmaceuticals LLCANDACurrent
90096-135ChlorproMAZINE HydrochlorideChlorproMAZINE HydrochlorideZameer Pharmaceuticals LLCANDACurrent