Details for New Drug Application (NDA): 022161
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NDA 022161 describes LEXISCAN, which is a drug marketed by Astellas and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LEXISCAN profile page.
The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.
The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.
Summary for 022161
| Tradename: | LEXISCAN |
| Applicant: | Astellas |
| Ingredient: | regadenoson |
| Patents: | 2 |
Pharmacology for NDA: 022161
| Mechanism of Action | Adenosine Receptor Agonists |
Suppliers and Packaging for NDA: 022161
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161 | NDA | Astellas Pharma US, Inc. | 0469-6501 | 0469-6501-89 | 5 mL in 1 SYRINGE, PLASTIC (0469-6501-89) |
| LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1448 | 51662-1448-1 | 1 SYRINGE, PLASTIC in 1 CARTON (51662-1448-1) / 5 mL in 1 SYRINGE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.4MG/5ML (0.08MG/ML) | ||||
| Approval Date: | Apr 10, 2008 | TE: | AP | RLD: | Yes | ||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 2, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 2, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022161
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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