Details for New Drug Application (NDA): 219921
✉ Email this page to a colleague
NDA 219921 describes KYXATA, which is a drug marketed by Avyxa Holdings 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 KYXATA profile page.
The generic ingredient in KYXATA is carboplatin. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
The generic ingredient in KYXATA is carboplatin. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
Summary for 219921
| Tradename: | KYXATA |
| Applicant: | Avyxa Holdings |
| Ingredient: | carboplatin |
| Patents: | 1 |
Suppliers and Packaging for NDA: 219921
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KYXATA | carboplatin | SOLUTION;INTRAVENOUS | 219921 | NDA | Avyxa Pharma, LLC | 83831-141 | 83831-141-08 | 1 VIAL, MULTI-DOSE in 1 CARTON (83831-141-08) / 8 mL in 1 VIAL, MULTI-DOSE |
| KYXATA | carboplatin | SOLUTION;INTRAVENOUS | 219921 | NDA | Avyxa Pharma, LLC | 83831-142 | 83831-142-50 | 1 VIAL, MULTI-DOSE in 1 CARTON (83831-142-50) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/2ML (10MG/ML) | ||||
| Approval Date: | Aug 8, 2025 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 1, 2045 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 80MG/8ML (10MG/ML) | ||||
| Approval Date: | Aug 8, 2025 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 1, 2045 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/50ML (10MG/ML) | ||||
| Approval Date: | Aug 8, 2025 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 1, 2045 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
