Details for New Drug Application (NDA): 203407
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NDA 203407 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Eugia Pharma Speclts, Hikma, Hospira, Mylan, Pharmachemie Bv, Sagent Pharms Inc, and Sandoz Inc, and is included in thirteen NDAs. It is available from four suppliers. Additional details are available on the METHOTREXATE SODIUM PRESERVATIVE FREE profile page.
The generic ingredient in METHOTREXATE SODIUM PRESERVATIVE FREE is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
The generic ingredient in METHOTREXATE SODIUM PRESERVATIVE FREE is methotrexate sodium. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 203407
| Tradename: | METHOTREXATE SODIUM PRESERVATIVE FREE |
| Applicant: | Sagent Pharms Inc |
| Ingredient: | methotrexate sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Aug 9, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Aug 9, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Aug 9, 2018 | TE: | AP | RLD: | No | ||||
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