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Pioglitazone

These highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets. Pioglitazone Tablets for oral useInitial U.S. Approval: 1999

Approved
Approval ID

a3ae5cba-f495-4593-b8fc-5ada34790745

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 31, 2012

Manufacturers
FDA

MedVantx, Inc.

DUNS: 806427725

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

pioglitazone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66116-504
Application NumberNDA021073
Product Classification
M
Marketing Category
C73605
G
Generic Name
pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2012
FDA Product Classification

INGREDIENTS (5)

pioglitazone hydrochlorideActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
carboxymethylcellulose calciumInactive
Code: UTY7PDF93L
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT

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Pioglitazone - FDA Drug Approval Details