Details for New Drug Application (NDA): 216298
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NDA 216298 describes PHYTONADIONE, which is a drug marketed by Alembic, Amneal, Baxter Hlthcare Corp, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Orbicular, Sunny, Agnitio, Amneal Pharms Co, Hikma, Sciegen Pharms, Sinotherapeutics Inc, and Zydus Lifesciences, and is included in nineteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the PHYTONADIONE profile page.
The generic ingredient in PHYTONADIONE is phytonadione. There are ten drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
The generic ingredient in PHYTONADIONE is phytonadione. There are ten drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 216298
| Tradename: | PHYTONADIONE |
| Applicant: | Orbicular |
| Ingredient: | phytonadione |
| Patents: | 0 |
Pharmacology for NDA: 216298
| Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 216298
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 216298 | ANDA | Orbicular Pharmaceutical Technologies Private Limited | 81607-020 | 81607-020-02 | 10 CARTON in 1 CARTON (81607-020-02) / 1 BLISTER PACK in 1 CARTON (81607-020-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/0.5ML | ||||
| Approval Date: | Mar 13, 2026 | TE: | AB1 | RLD: | No | ||||
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