Sodium Iodide I 131, Kit

   
Google
 
Web NewDrugInformation.com

Sodium Iodide I 131, Kit


Drug - Sodium Iodide I 131, Kit
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Sodium Iodide, I-131
Multiple ingredients are in alphabetical order.

Strength - 1-250mCi/0.25ML
The potency of the active ingredient(s), Sodium Iodide, I-131. May repeat for multiple part products.

Applicant - DRAXIMAGE
The firm name holding legal responsibility for Sodium Iodide I 131, Kit. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021305
The FDA assigned number to Sodium Iodide I 131, Kit. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Sodium Iodide I 131, Kit. 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 24, 2003
The date Sodium Iodide I 131, Kit 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) - Yes
The pioneer or innovator of Sodium Iodide I 131, Kit. 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 Sodium Iodide I 131, Kit 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 Sodium Iodide I 131, Kit.

Sodium Iodide I 131, Kit