FDA.reportPublic FDA data

Application 020504

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICROZIDEHYDROCHLOROTHIAZIDECAPSULE;ORAL12.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6154MicrozideHydrochlorothiazideAllergan, Inc.NDACurrent
0023-6154MicrozideHydrochlorothiazideAllergan, Inc.NDACurrent
0591-0347HydrochlorothiazideHydrochlorothiazideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-0347HydrochlorothiazideHydrochlorothiazideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-0347HydrochlorothiazideHydrochlorothiazideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-0347HydrochlorothiazideHydrochlorothiazideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-0347HydrochlorothiazideHydrochlorothiazideActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0615-1358HydrochlorothiazideHydrochlorothiazideNCS HealthCare of KY, Inc dba Vangard LabsNDA AUTHORIZED GENERICCurrent
10544-197HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.NDA AUTHORIZED GENERICCurrent
10544-198HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.NDA AUTHORIZED GENERICCurrent
42708-027HydrochlorothiazideHydrochlorothiazideQPharma IncNDA AUTHORIZED GENERICCurrent
42708-027HydrochlorothiazideHydrochlorothiazideQPharma IncNDA AUTHORIZED GENERICCurrent
42708-027HydrochlorothiazideHydrochlorothiazideQPharma IncNDA AUTHORIZED GENERICCurrent
52544-622MicrozideHydrochlorothiazideActavis Pharma, Inc.NDACurrent
55289-565HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-565HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-565HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-565HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-565HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-565HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-565HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-565HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, InNDA AUTHORIZED Current
63187-548HydrochlorothiazideHydrochlorothiazideProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-548HydrochlorothiazideHydrochlorothiazideProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-548HydrochlorothiazideHydrochlorothiazideProficient Rx LPNDA AUTHORIZED GENERICCurrent
63629-6463HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-6463HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
67544-739HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
68071-4176HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-4176HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68788-9867HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64354SUPPL2020-08-21
64332SUPPL2020-08-20
34721SUPPL2011-03-21
25058SUPPL2011-03-21