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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 021842


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NDA 021842 describes ACTOPLUS MET, which is a drug marketed by Takeda Pharms Usa and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ACTOPLUS MET profile page.

The generic ingredient in ACTOPLUS MET 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 021842
Suppliers and Packaging for NDA: 021842
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842 NDA Takeda Pharmaceuticals America, Inc. 64764-158 64764-158-18 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-18)
ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842 NDA Takeda Pharmaceuticals America, Inc. 64764-158 64764-158-41 4 CARTON in 1 TRAY (64764-158-41) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 29, 2005TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 22, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Feb 3, 2029Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG;EQ 15MG BASE
Approval Date:Aug 29, 2005TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 22, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021842

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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 verification 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.