Details for New Drug Application (NDA): 200833
✉ Email this page to a colleague
NDA 200833 describes CASPOFUNGIN ACETATE, which is a drug marketed by Areva Pharms, Cipla, Fresenius Kabi Usa, Gland, Hengrui Pharma, Norvium Bioscience, and Xellia Pharms Aps, and is included in seven NDAs. It is available from seven suppliers. There is one patent protecting this drug. Additional details are available on the CASPOFUNGIN ACETATE profile page.
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.
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 200833
| Tradename: | CASPOFUNGIN ACETATE |
| Applicant: | Hengrui Pharma |
| Ingredient: | caspofungin acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200833
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 200833 | ANDA | Sandoz Inc | 0781-3421 | 0781-3421-94 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3421-94) / 10.8 mL in 1 VIAL, SINGLE-DOSE (0781-3421-01) |
| CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 200833 | ANDA | Sandoz Inc | 0781-3423 | 0781-3423-94 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3423-94) / 10.8 mL in 1 VIAL, SINGLE-DOSE (0781-3423-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 50MG/VIAL | ||||
| Approval Date: | Jun 28, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 70MG/VIAL | ||||
| Approval Date: | Jun 28, 2018 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
