Details for New Drug Application (NDA): 022363
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NDA 022363 describes LIVALO, which is a drug marketed by Kowa Co and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LIVALO profile page.
The generic ingredient in LIVALO is pitavastatin calcium. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.
The generic ingredient in LIVALO is pitavastatin calcium. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.
Summary for 022363
| Tradename: | LIVALO |
| Applicant: | Kowa Co |
| Ingredient: | pitavastatin calcium |
| Patents: | 2 |
Pharmacology for NDA: 022363
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Suppliers and Packaging for NDA: 022363
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIVALO | pitavastatin calcium | TABLET;ORAL | 022363 | NDA | Kowa Pharmaceuticals America, Inc. | 66869-104 | 66869-104-90 | 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-104-90) |
| LIVALO | pitavastatin calcium | TABLET;ORAL | 022363 | NDA | Kowa Pharmaceuticals America, Inc. | 66869-204 | 66869-204-90 | 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-204-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Aug 3, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Aug 19, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Aug 2, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Aug 3, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Aug 19, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 022363
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-001 | Aug 3, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-001 | Aug 3, 2009 | ⤷ Subscribe | ⤷ Subscribe |
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