FDA.reportPublic FDA data

Application 076798

Type
ANDA
Sponsor
CELLTRION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 15MG BASENoNo
002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 30MG BASENoNo
003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 45MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2639Pioglitazone HydrochloridePioglitazone HydrochlorideA-S Medication SolutionsANDACurrent
50090-5582Pioglitazone HydrochloridePioglitazone HydrochlorideA-S Medication SolutionsANDACurrent
50090-5582Pioglitazone HydrochloridePioglitazone HydrochlorideA-S Medication SolutionsANDACurrent
68788-6420Pioglitazone HydrochloridePioglitazone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
71335-2027Pioglitazone HydrochloridePioglitazone HydrochlorideBryant Ranch PrepackANDACurrent
71335-2082Pioglitazone HydrochloridePioglitazone HydrochlorideBryant Ranch PrepackANDACurrent
72606-501Pioglitazone HydrochloridePioglitazone HydrochlorideCELLTRION USA, INC.ANDACurrent
72606-502Pioglitazone HydrochloridePioglitazone HydrochlorideCELLTRION USA, INC.ANDACurrent
72606-503Pioglitazone HydrochloridePioglitazone HydrochlorideCELLTRION USA, INC.ANDACurrent
72606-570Pioglitazone HydrochloridePioglitazone HydrochlorideCELLTRION USA, INC.ANDACurrent
72606-571Pioglitazone HydrochloridePioglitazone HydrochlorideCELLTRION USA, INC.ANDACurrent
72606-572Pioglitazone HydrochloridePioglitazone HydrochlorideCELLTRION USA, INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8965ORIG2012-08-23
44321ORIG2009-11-12