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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 three suppliers. Additional details are available on the VITAMIN K1 profile page.

The generic ingredient in VITAMIN K1 is phytonadione. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

Summary for NDA: 087954


Pharmacology for NDA: 087954

Suppliers and Packaging for NDA: 087954

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 087954 ANDA Hospira, Inc. 0409-9157 0409-9157-01 5 TRAY in 1 CONTAINER (0409-9157-01) > 5 AMPULE in 1 TRAY > .5 mL in 1 AMPULE
INJECTABLE;INJECTION 087954 ANDA Hospira, Inc. 0409-9157 0409-9157-25 5 TRAY in 1 CONTAINER (0409-9157-25) > 5 AMPULE in 1 TRAY > .5 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/0.5ML
Approval Date:Jul 25, 1983TE:BPRLD:Yes

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