FDA.reportPublic FDA data

Application 084878

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL50MGNoNo
002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1256HydrochlorothiazideHydrochlorothiazideWest-ward Pharmaceutical CorpANDACurrent
0143-1257HydrochlorothiazideHydrochlorothiazideWest-ward Pharmaceutical CorpANDACurrent
21695-538HydrochlorothiazideHydrochlorothiazideRebel Distributors CorpANDACurrent
21695-539HydrochlorothiazideHydrochlorothiazideRebel Distributors CorpANDACurrent
53808-0266HydrochlorothiazideHydrochlorothiazideState of Florida DOH Central PharmacyANDACurrent
55289-136HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
67046-271HydrochlorothiazideHydrochlorothiazideContract Pharmacy Services-PAANDACurrent
67046-272HydrochlorothiazideHydrochlorothiazideContract Pharmacy Services-PAANDACurrent