FDA.reportPublic FDA data

Application 076801

Type
ANDA
Sponsor
MYLAN PHARMS INC

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
0378-0048PioglitazonepioglitazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0048PioglitazonepioglitazoneMylan Pharmaceuticals IncANDACurrent
0378-0228PioglitazonepioglitazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0228PioglitazonepioglitazoneMylan Pharmaceuticals IncANDACurrent
0378-0318PioglitazonepioglitazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-0318PioglitazonepioglitazoneMylan Pharmaceuticals IncANDACurrent
51079-513PioglitazonepioglitazoneMylan Institutional Inc.ANDACurrent
51079-514PioglitazonepioglitazoneMylan Institutional Inc.ANDACurrent
51079-515PioglitazonepioglitazoneMylan Institutional Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8966ORIG2012-08-21
44322ORIG2009-11-12