Details for New Drug Application (NDA): 220454
NDA 220454 describes PHYTONADIONE, which is a drug marketed by Alembic, Amneal, Baxter Hlthcare Corp, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Lupin, Orbicular, Sunny, Amneal Pharms Co, Hikma, Novax, Sciegen Pharms, Tp Anda Holdings, and Zydus Lifesciences, and is included in twenty-two NDAs. It is available from thirty-two suppliers. Additional details are available on the PHYTONADIONE profile page.
The generic ingredient in PHYTONADIONE is phytonadione. There is one drug master file entry for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
The generic ingredient in PHYTONADIONE is phytonadione. There is one drug master file entry for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 220454
| Tradename: | PHYTONADIONE |
| Applicant: | Novax |
| Ingredient: | phytonadione |
| Patents: | 0 |
Pharmacology for NDA: 220454
| Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 220454
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHYTONADIONE | phytonadione | TABLET;ORAL | 220454 | ANDA | Padagis US LLC | 0574-1850 | 0574-1850-30 | 1 BOTTLE in 1 CARTON (0574-1850-30) / 30 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 26, 2026 | TE: | AB | RLD: | No | ||||
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