Details for New Drug Application (NDA): 210661
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The generic ingredient in PEMETREXED is pemetrexed ditromethamine. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed ditromethamine profile page.
Summary for 210661
Tradename: | PEMETREXED |
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 |
---|---|---|---|---|---|---|---|---|
PEMETREXED | 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 |
PEMETREXED | 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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