Details for New Drug Application (NDA): 210189
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NDA 210189 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, Novax, Sciegen Pharms, and Zydus Lifesciences, and is included in twenty-one NDAs. It is available from thirty 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-one 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-one 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 | Safecor Health, LLC | 48433-160 | 48433-160-03 | 30 BLISTER PACK in 1 CARTON (48433-160-03) / 1 TABLET in 1 BLISTER PACK (48433-160-01) |
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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