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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
October 31, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pioglitazone(30 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Carilion Materials Management

079239644

Manufacturing Establishments1

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

Carilion Materials Management

Carilion Materials Management

Carilion Materials Management

079239644

Products1

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
68151-3798
Application Number
NDA021073
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
October 31, 2012
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671PClass: IACT
Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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