Teslascan

   
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Teslascan


Drug - Teslascan
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) - Mangafodipir Trisodium
Multiple ingredients are in alphabetical order.

Strength - 37.9MG/ML
The potency of the active ingredient(s), Mangafodipir Trisodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020652
The FDA assigned number to Teslascan. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Teslascan. 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 - Nov 26, 1997
The date Teslascan 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 Teslascan. 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 Teslascan 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 Teslascan.

Teslascan