Details for New Drug Application (NDA): 209373
✉ Email this page to a colleague
NDA 209373 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-eight 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. Thirty 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. Thirty 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 | ||||
Complete Access Available with Subscription
