Vitamin K1

   
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Vitamin K1


Drug - Vitamin K1
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Phytonadione
Multiple ingredients are in alphabetical order.

Strength - 10MG/ML
The potency of the active ingredient(s), Phytonadione. May repeat for multiple part products.

Applicant - HOSPIRA
The firm name holding legal responsibility for Vitamin K1. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087955
The FDA assigned number to Vitamin K1. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Vitamin K1. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - BP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jul 25, 1983
The date Vitamin K1 was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Vitamin K1. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Vitamin K1 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hospira Inc
The full name of the firm holding legal responsibility for the new application of Vitamin K1.

Vitamin K1