Xenon Xe 127

   
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Xenon Xe 127


Drug - Xenon Xe 127
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-127
Multiple ingredients are in alphabetical order.

Strength - 5mCi/VIAL
The potency of the active ingredient(s), Xenon, Xe-127. May repeat for multiple part products.

Applicant - MALLINCKRODT
The firm name holding legal responsibility for Xenon Xe 127. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018536
The FDA assigned number to Xenon Xe 127. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Xenon Xe 127. 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 - Oct 1, 1982
The date Xenon Xe 127 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 127. 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 127 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mallinckrodt Medical Inc
The full name of the firm holding legal responsibility for the new application of Xenon Xe 127.

Xenon Xe 127