Details for New Drug Application (NDA): 208746
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NDA 208746 describes PEMETREXED DITROMETHAMINE, which is a drug marketed by Hospira and is included in one NDA. It is available from one supplier. Additional details are available on the PEMETREXED DITROMETHAMINE profile page.
The generic ingredient in PEMETREXED DITROMETHAMINE 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 DITROMETHAMINE 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 208746
| Tradename: | PEMETREXED DITROMETHAMINE |
| Applicant: | Hospira |
| Ingredient: | pemetrexed ditromethamine |
| Patents: | 0 |
Pharmacology for NDA: 208746
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 208746
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PEMETREXED DITROMETHAMINE | pemetrexed ditromethamine | POWDER;INTRAVENOUS | 208746 | NDA | Hospira, Inc. | 0409-1060 | 0409-1060-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1060-01) / 4.2 mL in 1 VIAL, SINGLE-DOSE |
| PEMETREXED DITROMETHAMINE | pemetrexed ditromethamine | POWDER;INTRAVENOUS | 208746 | NDA | Hospira, Inc. | 0409-1061 | 0409-1061-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1061-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Jun 10, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jun 10, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Jun 10, 2022 | TE: | RLD: | Yes | |||||
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