Details for New Drug Application (NDA): 214408
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NDA 214408 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 214408
| Tradename: | PEMETREXED DISODIUM |
| Applicant: | Accord Hlthcare |
| Ingredient: | pemetrexed disodium |
| Patents: | 0 |
Pharmacology for NDA: 214408
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for 214408
Suppliers and Packaging for NDA: 214408
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PEMETREXED DISODIUM | pemetrexed disodium | SOLUTION;INTRAVENOUS | 214408 | NDA | Accord Healthcare Inc. | 16729-522 | 16729-522-05 | 1 VIAL in 1 CARTON (16729-522-05) / 20 mL in 1 VIAL |
| PEMETREXED DISODIUM | pemetrexed disodium | SOLUTION;INTRAVENOUS | 214408 | NDA | Accord Healthcare Inc. | 16729-522 | 16729-522-28 | 1 VIAL in 1 CARTON (16729-522-28) / 34 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Jul 19, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Jul 19, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Jul 19, 2022 | TE: | RLD: | Yes | |||||
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