FDA.reportPublic FDA data

Application 079245

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;12.5MGNoNo
002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDETABLET;ORAL20MG;12.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57237-026Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-026Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-026Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-027Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-027Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-027Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideRising Health, LLCANDACurrent
63629-6993Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-6993Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
65862-308Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-308Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-308Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-308Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-309Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-309Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-309Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-309Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent