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FDA Approval

Actos

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

FDA Approval Summary

Company
Effective Date
September 14, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pioglitazone(15 mg in 1 1)

Manufacturing Establishments1

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

Dispensing Solutions, Inc.

Dispensing Solutions, Inc.

066070785

Products2

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

Actos

Product Details

NDC Product Code
68258-5230
Application Number
NDA021073
Marketing Category
NDA (C73594)
Route of Administration
OCCLUSIVE DRESSING TECHNIQUE
Effective Date
September 14, 2011
carboxymethylcellulose calciumInactive
Code: UTY7PDF93LClass: IACT
Code: JQT35NPK6CClass: ACTIBQuantity: 15 mg in 1 1
hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT

Actos

Product Details

NDC Product Code
68258-3034
Application Number
NDA021073
Marketing Category
NDA (C73594)
Route of Administration
OCCLUSIVE DRESSING TECHNIQUE
Effective Date
September 14, 2011
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
Code: JQT35NPK6CClass: ACTIBQuantity: 30 mg in 1 1
hydroxypropyl celluloseInactive
Code: RFW2ET671PClass: IACT
carboxymethylcellulose calciumInactive
Code: UTY7PDF93LClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
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