Details for New Drug Application (NDA): 090384
NDA 090384 describes PEMETREXED DISODIUM, which is a drug marketed by Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Somerset Theraps Llc, Zydus Pharms, and Sandoz, and is included in twenty-three NDAs. It is available from sixteen suppliers. Additional details are available on the PEMETREXED DISODIUM profile page.
The generic ingredient in PEMETREXED DISODIUM is pemetrexed disodium. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.
The generic ingredient in PEMETREXED DISODIUM is pemetrexed disodium. There is one drug master file entry for this compound. Nineteen 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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