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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 use Initial U.S. Approval: 1999

Approved
Approval ID

9fe57786-5c7d-4b11-8fb4-de341e2e5128

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 5, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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 Code50090-6874
Application NumberANDA202467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pioglitazone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2022
FDA Product Classification

INGREDIENTS (5)

PIOGLITAZONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Pioglitazone - FDA Drug Approval Details