MedPath
FDA Approval

Actos

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

FDA Approval Summary

Effective Date
October 25, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pioglitazone(15 mg in 1 1)

Products3

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
64764-151
Application Number
NDA021073
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
June 1, 2020
Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1
carboxymethylcellulose calciumInactive
Code: UTY7PDF93LClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT

Actos

Product Details

NDC Product Code
64764-301
Application Number
NDA021073
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
June 1, 2020
Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1
carboxymethylcellulose calciumInactive
Code: UTY7PDF93LClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT

Actos

Product Details

NDC Product Code
64764-451
Application Number
NDA021073
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
June 1, 2020
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
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
© Copyright 2025. All Rights Reserved by MedPath