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Details for New Drug Application (NDA): 021925

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NDA 021925 describes DUETACT, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DUETACT profile page.

The generic ingredient in DUETACT is glimepiride; pioglitazone hydrochloride. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glimepiride; pioglitazone hydrochloride profile page.

Summary for NDA: 021925

Tradename:
DUETACT
Applicant:
Takeda Pharms Usa
Ingredient:
glimepiride; pioglitazone hydrochloride
Patents:7
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021925

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL 021925 NDA Takeda Pharmaceuticals America, Inc. 64764-302 64764-302-30 30 TABLET in 1 BOTTLE (64764-302-30)
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL 021925 NDA Takeda Pharmaceuticals America, Inc. 64764-302 64764-302-90 90 TABLET in 1 BOTTLE (64764-302-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG;30MG
Approval Date:Jul 28, 2006TE:ABRLD:Yes
Patent:7,538,125Patent Expiration:Jun 19, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:7,700,128Patent Expiration:Jan 30, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,071,130Patent Expiration:Jun 8, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021925

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 20064,687,777► subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 20066,329,404► subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-002Jul 28, 20066,303,640► subscribe
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