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FDA Approval

PIOGLITAZONEHYDROCHLORIDE

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

FDA Approval Summary

Company
Effective Date
February 17, 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.

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

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

PIOGLITAZONEHYDROCHLORIDE

Product Details

NDC Product Code
68071-4822
Application Number
ANDA091298
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 17, 2021
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1
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