Details for New Drug Application (NDA): 021506
The generic ingredient in MYCAMINE is micafungin sodium. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.
Summary for 021506
| Tradename: | MYCAMINE |
| Applicant: | Astellas |
| Ingredient: | micafungin sodium |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Mar 16, 2005 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 27, 2006 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021506
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-002 | Mar 16, 2005 | ⤷ Start Trial | ⤷ Start Trial |
| Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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