Details for New Drug Application (NDA): 209373
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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, 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 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 | American Health Packaging | 60687-381 | 60687-381-94 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-381-94) / 1 TABLET in 1 BLISTER PACK (60687-381-11) |
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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