Xenon Xe 133-v.S.S.

   
Google
 
Web NewDrugInformation.com

Xenon Xe 133-v.S.S.


Drug - Xenon Xe 133-v.S.S.
The trade name of the product as shown on the labeling.

Dosage - GAS; INHALATION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Xenon, Xe-133
Multiple ingredients are in alphabetical order.

Strength - 10mCi/VIAL
The potency of the active ingredient(s), Xenon, Xe-133. May repeat for multiple part products.

Applicant - GE HEALTHCARE
The firm name holding legal responsibility for Xenon Xe 133-v.S.S.. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017687
The FDA assigned number to Xenon Xe 133-v.S.S.. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Xenon Xe 133-v.S.S.. 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 Xenon Xe 133-v.S.S. 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 Xenon Xe 133-v.S.S.. 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 Xenon Xe 133-v.S.S. 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 Xenon Xe 133-v.S.S..

Xenon Xe 133-v.S.S.