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Last Updated: August 10, 2020

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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 nine 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. Six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
Summary for 021842
Pharmacology for NDA: 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. 64764-155 64764-155-18 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-155-18)
ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842 NDA Takeda Pharmaceuticals America, Inc. 64764-155 64764-155-41 4 CARTON in 1 TRAY (64764-155-41) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 15MG BASE
Approval Date:Aug 29, 2005TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 22, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent 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:  Start TrialPatent Expiration:Jan 22, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021842

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Merck
Moodys
Boehringer Ingelheim
Medtronic

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