Technetium Tc 99m Generator

   
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Technetium Tc 99m Generator


Drug - Technetium Tc 99m Generator
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Technetium Tc-99m Sodium Pertechnetate Generator
Multiple ingredients are in alphabetical order.

Strength - 830-16600mCi/GENERATOR
The potency of the active ingredient(s), Technetium Tc-99m Sodium Pertechnetate Generator. May repeat for multiple part products.

Applicant - GE HEALTHCARE
The firm name holding legal responsibility for Technetium Tc 99m Generator. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017693
The FDA assigned number to Technetium Tc 99m Generator. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Technetium Tc 99m Generator. 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 Technetium Tc 99m Generator 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 Technetium Tc 99m Generator. 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 Technetium Tc 99m Generator 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 Technetium Tc 99m Generator.

Technetium Tc 99m Generator