Details for New Drug Application (NDA): 217386
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NDA 217386 describes PHYTONADIONE, which is a drug marketed by Cipla, Dr Reddys, Gland Pharma Ltd, Glaxosmithkline, Intl Medication, Agnitio, Amneal Pharms Co, Hikma, Sciegen Pharms Inc, and Zydus Lifesciences, and is included in twelve NDAs. It is available from seventeen 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 217386
| Tradename: | PHYTONADIONE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | phytonadione |
| Patents: | 0 |
Pharmacology for NDA: 217386
| Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 217386
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 217386 | ANDA | Gland Pharma Limited | 68083-606 | 68083-606-25 | 5 TRAY in 1 CARTON (68083-606-25) / 5 AMPULE in 1 TRAY (68083-606-05) / 1 mL in 1 AMPULE |
| PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 217386 | ANDA | GLENMARK PHARMACEUTICALS INC | 68462-758 | 68462-758-25 | 5 TRAY in 1 CARTON (68462-758-25) / 5 AMPULE in 1 TRAY (68462-758-05) / 1 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Dec 10, 2024 | TE: | AB1 | RLD: | No | ||||
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