FDA.reportPublic FDA data

Application 040807

Type
ANDA
Sponsor
IPCA LABS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-047HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
10544-136HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
23155-046HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-046HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-047HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-047HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-137HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-137HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
42254-132HydrochlorothiazideHydrochlorothiazideRebel Distributors CorpANDACurrent
50436-3919HydrochlorothiazideHydrochlorothiazideUnit Dose ServicesANDACurrent
51655-126HydrochlorothiazideHydrochlorothiazideNorthwind Pharmaceuticals, LLCANDACurrent
52959-132HydrochlorothiazideHydrochlorothiazideH.J. Harkins Company, Inc.ANDACurrent
63187-074HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
63187-074HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
64725-0047HydrochlorothiazideHydrochlorothiazideTYA PharmaceuticalsANDACurrent
67046-277HydrochlorothiazideHydrochlorothiazideContract Pharmacy Services-PAANDACurrent
68788-9401HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9401HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent