Details for New Drug Application (NDA): 211226
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NDA 211226 describes KHAPZORY, which is a drug marketed by Acrotech Biopharma and is included in one NDA. It is available from one supplier. Additional details are available on the KHAPZORY profile page.
The generic ingredient in KHAPZORY is levoleucovorin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the levoleucovorin profile page.
The generic ingredient in KHAPZORY is levoleucovorin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the levoleucovorin profile page.
Summary for 211226
| Tradename: | KHAPZORY |
| Applicant: | Acrotech Biopharma |
| Ingredient: | levoleucovorin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211226
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KHAPZORY | levoleucovorin | POWDER;INTRAVENOUS | 211226 | NDA | Acrotech Biopharma Inc | 72893-004 | 72893-004-01 | 1 VIAL in 1 CARTON (72893-004-01) / 3.5 mL in 1 VIAL |
| KHAPZORY | levoleucovorin | POWDER;INTRAVENOUS | 211226 | NDA | Acrotech Biopharma Inc | 72893-006 | 72893-006-01 | 1 VIAL in 1 CARTON (72893-006-01) / 6 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 175MG/VIAL | ||||
| Approval Date: | Oct 19, 2018 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 300MG/VIAL | ||||
| Approval Date: | Oct 19, 2018 | TE: | RLD: | Yes | |||||
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