Details for New Drug Application (NDA): 021632
NDA 021632 describes ERAXIS, which is a drug marketed by Vicuron Holdings and is included in one NDA. It is available from one supplier. Additional details are available on the ERAXIS profile page.
The generic ingredient in ERAXIS is anidulafungin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the anidulafungin profile page.
The generic ingredient in ERAXIS is anidulafungin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the anidulafungin profile page.
Summary for 021632
| Tradename: | ERAXIS |
| Applicant: | Vicuron Holdings |
| Ingredient: | anidulafungin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021632
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632 | NDA | Roerig | 0049-0114 | 0049-0114-28 | 15 mL in 1 VIAL, SINGLE-USE (0049-0114-28) |
| ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632 | NDA | Roerig | 0049-0116 | 0049-0116-28 | 30 mL in 1 VIAL, SINGLE-USE (0049-0116-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 50MG/VIAL | ||||
| Approval Date: | Feb 17, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Nov 14, 2006 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021632
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-002 | Nov 14, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-002 | Nov 14, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-002 | Nov 14, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-002 | Nov 14, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Vicuron Holdings | ERAXIS | anidulafungin | POWDER;INTRAVENOUS | 021632-001 | Feb 17, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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