Details for New Drug Application (NDA): 089343
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NDA 089343 describes METHOTREXATE SODIUM PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Eugia Pharma Speclts, Hikma, Hospira, Pharmachemie Bv, Rising, Sagent Pharms Inc, and Sandoz, 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the methotrexate sodium profile page.
Summary for 089343
| Tradename: | METHOTREXATE SODIUM PRESERVATIVE FREE |
| Applicant: | Hikma |
| Ingredient: | methotrexate sodium |
| Patents: | 0 |
Pharmacology for NDA: 089343
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 089343
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHOTREXATE SODIUM PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 089343 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9516 | 0143-9516-01 | 1 VIAL in 1 BOX (0143-9516-01) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | ||||
| Approval Date: | Sep 16, 1986 | TE: | AP | RLD: | No | ||||
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