Technescan Gluceptate

   
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Technescan Gluceptate


Drug - Technescan Gluceptate
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) - Technetium Tc-99m Gluceptate Kit
Multiple ingredients are in alphabetical order.

Strength - N/A
The potency of the active ingredient(s), Technetium Tc-99m Gluceptate Kit. May repeat for multiple part products.

Applicant - DRAXIMAGE
The firm name holding legal responsibility for Technescan Gluceptate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018272
The FDA assigned number to Technescan Gluceptate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Technescan Gluceptate. 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 - Jan 27, 1982
The date Technescan Gluceptate 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 Technescan Gluceptate. 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 Technescan Gluceptate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Draximage Inc
The full name of the firm holding legal responsibility for the new application of Technescan Gluceptate.

Technescan Gluceptate