FDA.reportPublic FDA data

Application 040907

Type
ANDA
Sponsor
UNICHEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL25MGNoNo
002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL50MGNoNo
003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL12.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0065HydrochlorothiazideHydrochlorothiazideKAISER FOUNDATION HOSPITALSANDACurrent
10544-900HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
29300-128HydrochlorothiazideHydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-128HydrochlorothiazideHydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-128HydrochlorothiazideHydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-128HydrochlorothiazideHydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-129HydrochlorothiazideHydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-129HydrochlorothiazideHydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-129HydrochlorothiazideHydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-129HydrochlorothiazideHydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
42708-079HydrochlorothiazideHydrochlorothiazideQPharma IncANDACurrent
42708-079HydrochlorothiazideHydrochlorothiazideQPharma IncANDACurrent
50090-0140HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0141HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0141HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0141HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5057HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5057HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
55700-006HydrochlorothiazideHydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-006HydrochlorothiazideHydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-006HydrochlorothiazideHydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-006HydrochlorothiazideHydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-006HydrochlorothiazideHydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0123HydrochlorothiazideHydrochlorothiazideClinical Solutions Wholesale, LLCANDACurrent
58118-0123HydrochlorothiazideHydrochlorothiazideClinical Solutions Wholesale, LLCANDACurrent
58118-0123HydrochlorothiazideHydrochlorothiazideClinical Solutions Wholesale, LLCANDACurrent
60760-315HydrochlorothiazideHydrochlorothiazideSt. Mary's Medical Park PharmacyANDACurrent
61919-293HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDirect_RxANDACurrent
61919-293HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDirect_RxANDACurrent
61919-293HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDirect_RxANDACurrent
61919-293HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDirect_RxANDACurrent
61919-293HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDIRECT RXANDACurrent
61919-293HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDirect_RxANDACurrent
61919-293HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDirect_RxANDACurrent
68071-3238HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4807HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4807HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4933HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4933HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9965HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9965HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9965HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9965HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
70934-789HydrochlorothiazideHydrochlorothiazideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-789HydrochlorothiazideHydrochlorothiazideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-419HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
71205-419HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
71335-0652HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0652HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0652HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1976HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1976HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71610-323HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
76282-154HydrochlorothiazideHydrochlorothiazideExelan Pharmaceuticals Inc.ANDACurrent
76282-155HydrochlorothiazideHydrochlorothiazideExelan Pharmaceuticals Inc.ANDACurrent