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 one supplier. 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 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

Pharmacology for NDA: 021073

Mechanism of Action	Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 15MG BASE
Approval Date:	Jul 15, 1999	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 30MG BASE
Approval Date:	Jul 15, 1999	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 45MG BASE
Approval Date:	Jul 15, 1999	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021073

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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	6,150,383	⤷ Start Trial
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	6,303,640	⤷ Start Trial
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999	6,271,243	⤷ Start Trial
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999	6,329,404	⤷ Start Trial
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999	4,444,779	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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