Details for New Drug Application (NDA): 090384
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The generic ingredient in PEMETREXED DISODIUM is pemetrexed disodium. There are twenty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.
Summary for 090384
Tradename: | PEMETREXED DISODIUM |
Applicant: | Fresenius Kabi Usa |
Ingredient: | pemetrexed disodium |
Patents: | 0 |
Pharmacology for NDA: 090384
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for 090384
Suppliers and Packaging for NDA: 090384
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 090384 | ANDA | Fresenius Kabi USA, LLC | 63323-134 | 63323-134-10 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-134-10) / 4 mL in 1 VIAL, SINGLE-USE |
PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 090384 | ANDA | Fresenius Kabi USA, LLC | 63323-450 | 63323-450-50 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-450-50) / 20 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
Approval Date: | May 25, 2022 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL | ||||
Approval Date: | May 25, 2022 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 750MG BASE/VIAL | ||||
Approval Date: | May 25, 2022 | TE: | AP | RLD: | No |
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