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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. It is available from one supplier. There are fifteen 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-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.

Summary for NDA: 022024

Tradename:
ACTOPLUS MET XR
Applicant:
Takeda Pharms Usa
Ingredient:
metformin hydrochloride; pioglitazone hydrochloride
Patents:15
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022024

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 022024 NDA Takeda Pharmaceuticals America, Inc. 64764-310 64764-310-07 1 BLISTER PACK in 1 CARTON (64764-310-07) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 022024 NDA Takeda Pharmaceuticals America, Inc. 64764-310 64764-310-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (64764-310-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM;EQ 15MG BASE
Approval Date:May 12, 2009TE:RLD:No
Patent:6,099,859Patent Expiration:Mar 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,495,162Patent Expiration:Mar 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,866,866Patent Expiration:Mar 17, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022024

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;ORAL022024-001May 12, 20094,687,777► subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 20096,172,090► subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 20095,965,584► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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