DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 010104
NDA 010104 describes MEPHYTON, which is a drug marketed by Valeant Pharms and is included in one NDA. It is available from six suppliers. Additional details are available on the MEPHYTON profile page.
The generic ingredient in MEPHYTON is phytonadione. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
The generic ingredient in MEPHYTON is phytonadione. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 010104
| Tradename: | MEPHYTON |
| Applicant: | Valeant Pharms |
| Ingredient: | phytonadione |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 010104
| Ingredient-type | Vitamin K |
| Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 010104
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEPHYTON | phytonadione | TABLET;ORAL | 010104 | NDA | KAISER FOUNDATION HOSPITALS | 0179-0133 | N | 0179-0133-70 |
| MEPHYTON | phytonadione | TABLET;ORAL | 010104 | NDA | Valeant Pharmaceuticals North America LLC | 0187-1704 | N | 0187-1704-05 |
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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