FDA.reportPublic FDA data

Application 090406

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL500MG;EQ 15MG BASENoNo
002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDETABLET;ORAL850MG;EQ 15MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1550Pioglitazone Hydrochloride and Metformin Hydrochloridepioglitazone hydrochloride and metformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1550Pioglitazone Hydrochloride and Metformin Hydrochloridepioglitazone hydrochloride and metformin hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-1575Pioglitazone Hydrochloride and Metformin Hydrochloridepioglitazone hydrochloride and metformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1575Pioglitazone Hydrochloride and Metformin Hydrochloridepioglitazone hydrochloride and metformin hydrochlorideMylan Pharmaceuticals IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43238ORIG2012-02-12