Details for New Drug Application (NDA): 011719
✉ Email this page to a colleague
NDA 011719 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Caplin One Labs, Eugia Pharma Speclts, Extrovis, Hikma, Hospira, Pharmachemie Bv, and Sagent Pharms Inc, and is included in thirteen NDAs. It is available from five 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. Thirty 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. Thirty suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 011719
| Tradename: | METHOTREXATE SODIUM PRESERVATIVE FREE |
| Applicant: | Hospira |
| Ingredient: | methotrexate sodium |
| Patents: | 0 |
Pharmacology for NDA: 011719
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 011719
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHOTREXATE LPF | methotrexate sodium | INJECTABLE;INJECTION | 011719 | NDA | Hospira, Inc. | 61703-124 | 61703-124-40 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-124-40) / 40 mL in 1 VIAL, SINGLE-DOSE |
| METHOTREXATE PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 011719 | NDA | Hospira, Inc. | 61703-124 | 61703-124-40 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-124-40) / 40 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
