Details for New Drug Application (NDA): 207719
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NDA 207719 describes PHYTONADIONE, which is a drug marketed by Cipla, Dr Reddys, Glaxosmithkline, Intl Medication, Agnitio, Amneal Pharms Co, Sciegen Pharms Inc, and Zydus Lifesciences, and is included in nine NDAs. It is available from fifteen 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 207719
| Tradename: | PHYTONADIONE |
| Applicant: | Dr Reddys |
| Ingredient: | phytonadione |
| Patents: | 0 |
Pharmacology for NDA: 207719
| Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 207719
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 207719 | ANDA | Henry Schein, Inc. | 0404-9969 | 0404-9969-01 | 1 AMPULE in 1 BAG (0404-9969-01) / 1 mL in 1 AMPULE |
| PHYTONADIONE | phytonadione | INJECTABLE;INJECTION | 207719 | ANDA | Dr.Reddy's Laboratories Inc | 43598-405 | 43598-405-16 | 25 AMPULE in 1 CARTON (43598-405-16) / 1 mL in 1 AMPULE (43598-405-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | May 22, 2019 | TE: | AB1 | RLD: | No | ||||
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