Details for New Drug Application (NDA): 209373
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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 209373
Tradename: | PHYTONADIONE |
Applicant: | Amneal Pharms Co |
Ingredient: | phytonadione |
Patents: | 0 |
Pharmacology for NDA: 209373
Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 209373
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHYTONADIONE | phytonadione | TABLET;ORAL | 209373 | ANDA | Major Pharmaceuticals | 0904-6882 | 0904-6882-10 | 20 BLISTER PACK in 1 CARTON (0904-6882-10) / 1 TABLET in 1 BLISTER PACK |
PHYTONADIONE | phytonadione | TABLET;ORAL | 209373 | ANDA | AvKARE | 42291-566 | 42291-566-30 | 1 BOTTLE in 1 BOX (42291-566-30) / 30 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | May 11, 2018 | TE: | AB | RLD: | No |
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