Details for New Drug Application (NDA): 022024

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NDA 022024 describes ACTOPLUS MET XR, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ACTOPLUS MET XR profile page.

The generic ingredient in ACTOPLUS MET XR is metformin hydrochloride; pioglitazone hydrochloride. There are forty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.

Summary for 022024

Tradename:	ACTOPLUS MET XR
Applicant:	Takeda Pharms Usa
Ingredient:	metformin hydrochloride; pioglitazone hydrochloride
Patents:	2

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM;EQ 15MG BASE
Approval Date:	May 12, 2009	TE:		RLD:	Yes
Patent:	7,785,627	Patent Expiration:	Jul 31, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	7,959,946	Patent Expiration:	Jul 31, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM;EQ 30MG BASE
Approval Date:	May 12, 2009	TE:		RLD:	Yes
Patent:	7,785,627	Patent Expiration:	Jul 31, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022024

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009	7,919,116	⤷ Subscribe
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	6,166,043	⤷ Subscribe
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	6,866,866	⤷ Subscribe
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	8,470,368	⤷ Subscribe
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