Details for New Drug Application (NDA): 210189
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The generic ingredient in PHYTONADIONE is phytonadione. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 210189
Tradename: | PHYTONADIONE |
Applicant: | Zydus Lifesciences |
Ingredient: | phytonadione |
Patents: | 0 |
Pharmacology for NDA: 210189
Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 210189
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHYTONADIONE | phytonadione | TABLET;ORAL | 210189 | ANDA | Northstar Rx LLC. | 16714-973 | 16714-973-02 | 1 BOTTLE in 1 CARTON (16714-973-02) / 30 TABLET in 1 BOTTLE |
PHYTONADIONE | phytonadione | TABLET;ORAL | 210189 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1014 | 70710-1014-1 | 1 BOTTLE in 1 CARTON (70710-1014-1) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 20, 2019 | TE: | AB | RLD: | No |
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