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. There is one patent protecting this drug. 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: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211226
Generic Entry Date for 211226*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 211226
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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 175MG/VIAL | ||||
| Approval Date: | Oct 19, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Mar 25, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 300MG/VIAL | ||||
| Approval Date: | Oct 19, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Mar 25, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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