Details for New Drug Application (NDA): 021073
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NDA 021073 describes ACTOS, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the ACTOS profile page.
The generic ingredient in ACTOS is pioglitazone hydrochloride. There are twenty-seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the pioglitazone hydrochloride profile page.
The generic ingredient in ACTOS is pioglitazone hydrochloride. There are twenty-seven drug master file entries for this compound. Twenty-one 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 |
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
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