Details for New Drug Application (NDA): 021925
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The generic ingredient in DUETACT is glimepiride; pioglitazone hydrochloride. There are sixteen 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 021925
Tradename: | DUETACT |
Applicant: | Takeda Pharms Usa |
Ingredient: | glimepiride; pioglitazone hydrochloride |
Patents: | 2 |
Pharmacology for NDA: 021925
Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
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) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG;30MG | ||||
Approval Date: | Jul 28, 2006 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 30, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 8, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG;30MG | ||||
Approval Date: | Jul 28, 2006 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 30, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 021925
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-002 | Jul 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-002 | Jul 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-001 | Jul 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | DUETACT | glimepiride; pioglitazone hydrochloride | TABLET;ORAL | 021925-002 | Jul 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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