FDA.reportPublic FDA data

Application 040412

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-7595HydrochlorothiazideHydrochlorothiazideLiberty Pharmaceuticals, Inc.ANDACurrent
0615-1561HydrochlorothiazideHydrochlorothiazideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1562HydrochlorothiazideHydrochlorothiazideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-105HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
33261-158HydrochlorothiazideHydrochlorothiazideAidarex Pharmaceuticals LLCANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, InANDACurrent
43547-397HydrochlorothiazideHydrochlorothiazideSolco Healthcare U.S., LLCANDACurrent
43547-397HydrochlorothiazideHydrochlorothiazideSolco Healthcare U.S., LLCANDACurrent
43547-398HydrochlorothiazideHydrochlorothiazideSolco Healthcare U.S., LLCANDACurrent
43547-398HydrochlorothiazideHydrochlorothiazideSolco Healthcare U.S., LLCANDACurrent
50090-2213HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2214HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
55154-1483HydrochlorothiazideHydrochlorothiazideCardinal HealthANDACurrent
55154-1483HydrochlorothiazideHydrochlorothiazideCardinal HealthANDACurrent
55700-843HydrochlorothiazideHydrochlorothiazideQuality Care Products, LLCANDACurrent
55700-843HydrochlorothiazideHydrochlorothiazideQuality Care Products, LLCANDACurrent
60429-877HydrochlorothiazideHydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
60429-878HydrochlorothiazideHydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
60687-593HydrochlorothiazideHydrochlorothiazideAmerican Health PackagingANDACurrent
60687-593HydrochlorothiazideHydrochlorothiazideAmerican Health PackagingANDACurrent
63629-1121HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1121HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1121HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1218HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1218HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1219HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1219HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1220HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1220HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8991HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8992HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63739-128HydrochlorothiazideHydrochlorothiazideMcKesson CorporationANDACurrent
63739-128HydrochlorothiazideHydrochlorothiazideMcKesson Corporation dba SKY PackagingANDACurrent
63739-128HydrochlorothiazideHydrochlorothiazideMcKesson Corporation dba SKY PackagingANDACurrent
66336-184HydrochlorothiazideHydrochlorothiazideDispensing Solutions, Inc.ANDACurrent
67296-1682HydrochlorothiazideHydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67296-1682HydrochlorothiazideHydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67544-338HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-346HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
68645-341HydrochlorothiazideHydrochlorothiazideLegacy Pharmaceutical PackagingANDACurrent
68788-9919HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9920HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
70518-3002HydrochlorothiazideHydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71335-1451HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1451HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1481HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71610-261HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
76413-139HydrochlorothiazideHydrochlorothiazideCentral Texas Community Health CentersANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7653ORIG2003-04-09