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FDA Approval

Pioglitazone

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
August 7, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pioglitazone(30 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products2

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

Pioglitazone

Product Details

NDC Product Code
50090-2390
Application Number
ANDA077210
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 31, 2019
Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT

Pioglitazone

Product Details

NDC Product Code
50090-2401
Application Number
ANDA077210
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 31, 2019
Code: JQT35NPK6CClass: ACTIMQuantity: 45 mg in 1 1
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
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