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Last Updated: December 11, 2019

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Details for New Drug Application (NDA): 021073

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NDA 021073 describes ACTOS, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. Additional details are available on the ACTOS profile page.

The generic ingredient in ACTOS is pioglitazone hydrochloride. There are twenty-seven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the pioglitazone hydrochloride profile page.
Summary for 021073
Tradename:ACTOS
Applicant:Takeda Pharms Usa
Ingredient:pioglitazone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021073
Suppliers and Packaging for NDA: 021073
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTOS pioglitazone hydrochloride TABLET;ORAL 021073 NDA Takeda Pharmaceuticals America, Inc. 64764-151 64764-151-02 6 CARTON in 1 TRAY (64764-151-02) > 1 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK
ACTOS pioglitazone hydrochloride TABLET;ORAL 021073 NDA Takeda Pharmaceuticals America, Inc. 64764-151 64764-151-04 30 TABLET in 1 BOTTLE (64764-151-04)
Paragraph IV (Patent) Challenges for 021073
Tradename Dosage Ingredient NDA Submissiondate
ACTOS TABLET;ORAL pioglitazone hydrochloride 021073

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Jul 15, 1999TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jul 15, 1999TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 45MG BASE
Approval Date:Jul 15, 1999TE:ABRLD:Yes

Expired US Patents for NDA 021073

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-002 Jul 15, 1999   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-002 Jul 15, 1999   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-001 Jul 15, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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