Details for New Drug Application (NDA): 210661
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NDA 210661 describes AXTLE, which is a drug marketed by Avyxa Holdings and is included in one NDA. It is available from one supplier. Additional details are available on the AXTLE profile page.
The generic ingredient in AXTLE is pemetrexed dipotassium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed dipotassium profile page.
The generic ingredient in AXTLE is pemetrexed dipotassium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed dipotassium profile page.
Summary for 210661
| Tradename: | AXTLE |
| Applicant: | Avyxa Holdings |
| Ingredient: | pemetrexed dipotassium |
| Patents: | 0 |
Pharmacology for NDA: 210661
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 210661
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AXTLE | pemetrexed dipotassium | POWDER;INTRAVENOUS | 210661 | NDA | Avyxa Pharma, LLC | 83831-111 | 83831-111-01 | 1 VIAL in 1 CARTON (83831-111-01) / 4 mL in 1 VIAL |
| AXTLE | pemetrexed dipotassium | POWDER;INTRAVENOUS | 210661 | NDA | Avyxa Pharma, LLC | 83831-112 | 83831-112-01 | 1 VIAL in 1 CARTON (83831-112-01) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Jun 28, 2024 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jun 28, 2024 | TE: | RLD: | Yes | |||||
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