Details for New Drug Application (NDA): 021506
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The generic ingredient in MYCAMINE is micafungin sodium. There are eight drug master file entries for this compound. Thirteen 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 |
Suppliers and Packaging for NDA: 021506
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506 | NDA | Astellas Pharma US, Inc. | 0469-3211 | 0469-3211-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506 | NDA | Astellas Pharma US, Inc. | 0469-3250 | 0469-3250-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-10) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
Approval Date: | Mar 16, 2005 | TE: | AP | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
Approval Date: | Jun 27, 2006 | TE: | AP | 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 | ⤷ Sign Up | ⤷ Sign Up |
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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