Details for New Drug Application (NDA): 203485
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NDA 203485 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, Norvium Bioscience, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, and Sandoz, and is included in twenty-three NDAs. It is available from twenty suppliers. Additional details are available on the PEMETREXED DISODIUM profile page.
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.
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 203485
| Tradename: | PEMETREXED DISODIUM |
| Applicant: | Accord Hlthcare |
| Ingredient: | pemetrexed disodium |
| Patents: | 0 |
Pharmacology for NDA: 203485
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for 203485
Suppliers and Packaging for NDA: 203485
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 203485 | ANDA | Accord Healthcare Inc. | 16729-229 | 16729-229-03 | 1 VIAL in 1 CARTON (16729-229-03) / 4 mL in 1 VIAL |
| PEMETREXED DISODIUM | pemetrexed disodium | POWDER;INTRAVENOUS | 203485 | ANDA | Accord Healthcare Inc. | 16729-230 | 16729-230-11 | 1 VIAL in 1 CARTON (16729-230-11) / 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: | 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 1GM BASE/VIAL | ||||
| Approval Date: | May 25, 2022 | TE: | AP | RLD: | No | ||||
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