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Details for New Drug Application (NDA): 010104
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NDA 010104 describes MEPHYTON, which is a drug marketed by Bausch and is included in one NDA. It is available from three suppliers. Additional details are available on the MEPHYTON profile page.
The generic ingredient in MEPHYTON is phytonadione. There are ten 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 ten 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: | Bausch |
| Ingredient: | phytonadione |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 010104
| 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 | Bausch Health US LLC | 0187-1704 | 0187-1704-05 | 1 BOTTLE in 1 CARTON (0187-1704-05) > 100 TABLET in 1 BOTTLE |
| MEPHYTON | phytonadione | TABLET;ORAL | 010104 | NDA | A-S Medication Solutions | 50090-1753 | 50090-1753-0 | 5 TABLET in 1 BOTTLE (50090-1753-0) |
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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