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

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Menadiol Sodium Diphosphate
Multiple ingredients are in alphabetical order.

Strength - 5MG
The potency of the active ingredient(s), Menadiol Sodium Diphosphate. May repeat for multiple part products.

Applicant - ROCHE
The firm name holding legal responsibility for Synkayvite. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 003718
The FDA assigned number to Synkayvite. Format is nnnnnn.

Product Number - 010
The FDA assigned number to identify Synkayvite. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Approved Prior to Jan 1, 1982
The date Synkayvite 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 Synkayvite. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Synkayvite.