Details for New Drug Application (NDA): 201529
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NDA 201529 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Eugia Pharma Speclts, Extrovis, Hikma, Hospira, Pharmachemie Bv, Sagent Pharms Inc, and Sandoz, 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. Twenty-nine 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-nine suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 201529
| Tradename: | METHOTREXATE SODIUM PRESERVATIVE FREE |
| Applicant: | Eugia Pharma Speclts |
| Ingredient: | methotrexate sodium |
| Patents: | 0 |
Pharmacology for NDA: 201529
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 201529
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 201529 | ANDA | Eugia US LLC | 55150-510 | 55150-510-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-510-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
| METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 201529 | ANDA | Eugia US LLC | 55150-510 | 55150-510-05 | 5 VIAL, SINGLE-DOSE in 1 CARTON (55150-510-05) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Mar 29, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/4ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Mar 29, 2012 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/8ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Mar 29, 2012 | TE: | RLD: | No | |||||
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