Details for New Drug Application (NDA): 206110
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The generic ingredient in CASPOFUNGIN ACETATE is caspofungin acetate. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the caspofungin acetate profile page.
Summary for 206110
Tradename: | CASPOFUNGIN ACETATE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | caspofungin acetate |
Patents: | 1 |
Suppliers and Packaging for NDA: 206110
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 206110 | NDA | Fresenius Kabi USA, LLC | 63323-356 | 63323-356-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-356-10) / 10.8 mL in 1 VIAL, SINGLE-DOSE (63323-356-01) |
CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 206110 | NDA | Fresenius Kabi USA, LLC | 63323-358 | 63323-358-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-358-10) / 10.8 mL in 1 VIAL, SINGLE-DOSE (63323-358-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 50MG/VIAL | ||||
Approval Date: | Dec 30, 2016 | TE: | AP | RLD: | No | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 21, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 70MG/VIAL | ||||
Approval Date: | Dec 30, 2016 | TE: | AP | RLD: | No | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 21, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
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