Details for New Drug Application (NDA): 208419
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NDA 208419 describes PEMETREXED, which is a drug marketed by Avyxa Holdings, Actavis, Shilpa, 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-seven NDAs. It is available from four suppliers. There is one patent protecting this drug. Additional details are available on the PEMETREXED profile page.
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.
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 208419
| Tradename: | PEMETREXED |
| Applicant: | Actavis |
| Ingredient: | pemetrexed |
| Patents: | 0 |
Pharmacology for NDA: 208419
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 208419
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PEMETREXED | pemetrexed | SOLUTION;INTRAVENOUS | 208419 | NDA | Teva Pharmaceuticals, Inc. | 0480-4514 | 0480-4514-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4514-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
| PEMETREXED | pemetrexed | SOLUTION;INTRAVENOUS | 208419 | NDA | Teva Pharmaceuticals, Inc. | 0480-4515 | 0480-4515-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4515-01) / 40 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/4ML (25MG/ML) | ||||
| Approval Date: | Aug 21, 2020 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/20ML (25MG/ML) | ||||
| Approval Date: | Aug 21, 2020 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/40ML (25MG/ML) | ||||
| Approval Date: | Aug 21, 2020 | TE: | RLD: | Yes | |||||
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