Details for New Drug Application (NDA): 021073
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The generic ingredient in ACTOS is pioglitazone hydrochloride. There are twenty-seven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the pioglitazone hydrochloride profile page.
Summary for 021073
Tradename: | ACTOS |
Applicant: | Takeda Pharms Usa |
Ingredient: | pioglitazone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021073
Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
Suppliers and Packaging for NDA: 021073
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-151 | 64764-151-02 | 6 CARTON in 1 TRAY (64764-151-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK |
ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-151 | 64764-151-04 | 30 TABLET in 1 BOTTLE (64764-151-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
Approval Date: | Jul 15, 1999 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Jul 15, 1999 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 45MG BASE | ||||
Approval Date: | Jul 15, 1999 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021073
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-003 | Jul 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-001 | Jul 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073-003 | Jul 15, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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