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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
July 31, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pioglitazone(45 mg in 1 1)

Products3

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
0093-7273
Application Number
ANDA077210
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2021
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
Code: JQT35NPK6CClass: ACTIMQuantity: 45 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT

Pioglitazone

Product Details

NDC Product Code
0093-7271
Application Number
ANDA077210
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2021
Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT

Pioglitazone

Product Details

NDC Product Code
0093-7272
Application Number
ANDA077210
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 31, 2021
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
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