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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 five suppliers. There are seventeen 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-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: 021842

Tradename:
ACTOPLUS MET
Applicant:
Takeda Pharms Usa
Ingredient:
metformin hydrochloride; pioglitazone hydrochloride
Patents:6
Formulation / Manufacturing:see details

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 AUTHORIZED GENERIC Teva Pharmaceuticals USA 0093-5049 0093-5049-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-5049-06)
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL 021842 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA 0093-5049 0093-5049-86 180 TABLET, FILM COATED in 1 BOTTLE (0093-5049-86)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 15MG BASE
Approval Date:Aug 29, 2005TE:ABRLD:No
Patent:9,101,660Patent Expiration:Jan 22, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:9,320,714Patent Expiration:Feb 3, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:6,166,042Patent Expiration:Jun 19, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN

Expired Orange Book Patents for NDA: 021842

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-002Aug 29, 20054,687,777► subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-001Aug 29, 20054,687,777► subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-002Aug 29, 20056,166,043► subscribe
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