FDA.reportPublic FDA data

Application 040804

Type
ANDA
Sponsor
ECI PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-017Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-043Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-091Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
21695-208Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRebel Distributors CorpANDACurrent
21695-356Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRebel Distributors CorpANDACurrent
21695-378Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRebel Distributors CorpANDACurrent
23155-105Hydroxyzine HydrochlorideHydroxyzine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-106Hydroxyzine HydrochlorideHydroxyzine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-107Hydroxyzine HydrochlorideHydroxyzine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
50436-3874Hydroxyzine HydrochlorideHydroxyzine HydrochlorideUnit Dose ServicesANDACurrent
51655-078HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENorthwind Pharmaceuticals, LLCANDACurrent
51655-079HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDENorthwind Pharmaceuticals, LLCANDACurrent
52959-074Hydroxyzine HydrochlorideHydroxyzine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
61919-122HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-646HYDROXYZINE HCLHYDROXYZINE HCLDIRECT RXANDACurrent
61919-646HYDROXYZINE HCLHYDROXYZINE HCLDIRECT RXANDACurrent
63187-539Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
63187-605Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
63187-605Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
66267-112Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-112Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-113Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
67296-0648Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRedPharm Drug Inc.ANDACurrent
67296-0648HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-0648HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
68788-9307Hydroxyzine HydrochlorideHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent