Details for New Drug Application (NDA): 087954
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NDA 087954 describes VITAMIN K1, which is a drug marketed by Hospira and is included in three NDAs. It is available from two suppliers. Additional details are available on the VITAMIN K1 profile page.
The generic ingredient in VITAMIN K1 is phytonadione. There are ten drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
The generic ingredient in VITAMIN K1 is phytonadione. There are ten drug master file entries for this compound. Twenty-six 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 |
Pharmacology for NDA: 087954
| 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 | 0409-9157-01 | 5 TRAY in 1 CONTAINER (0409-9157-01) / 5 AMPULE in 1 TRAY (0409-9157-50) / .5 mL in 1 AMPULE (0409-9157-31) |
| VITAMIN K1 | phytonadione | INJECTABLE;INJECTION | 087954 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1537 | 51662-1537-3 | 25 POUCH in 1 BOX (51662-1537-3) / 1 AMPULE in 1 POUCH (51662-1537-2) / .5 mL in 1 AMPULE |
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: | Yes | ||||
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