DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 087954
The generic ingredient in VITAMIN K1 is phytonadione. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 087954
Tradename: | VITAMIN K1 |
Applicant: | Hospira |
Ingredient: | phytonadione |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 087954
Ingredient-type | Vitamin K |
Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 087954
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VITAMIN K1 | phytonadione | INJECTABLE;INJECTION | 087954 | ANDA | Hospira, Inc. | 0409-9157 | N | 0409-9157-25 |
VITAMIN K1 | phytonadione | INJECTABLE;INJECTION | 087954 | ANDA | Hospira, Inc. | 0409-9157 | N | 0409-9157-01 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/0.5ML | ||||
Approval Date: | Jul 25, 1983 | TE: | BP | RLD: | No |
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