Fluorine F-18

   
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Fluorine F-18


Drug - Fluorine F-18
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Sodium Fluoride, F-18
Multiple ingredients are in alphabetical order.

Strength - 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
The potency of the active ingredient(s), Sodium Fluoride, F-18. May repeat for multiple part products.

Applicant - GE HEALTHCARE
The firm name holding legal responsibility for Fluorine F-18. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017042
The FDA assigned number to Fluorine F-18. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Fluorine F-18. 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 Fluorine F-18 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 Fluorine F-18. 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 Fluorine F-18 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ge Healthcare
The full name of the firm holding legal responsibility for the new application of Fluorine F-18.

Fluorine F-18