Pylori-chek Breath Test

   
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Pylori-chek Breath Test


Drug - Pylori-chek Breath Test
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Urea, C-13
Multiple ingredients are in alphabetical order.

Strength - 100MG/VIAL
The potency of the active ingredient(s), Urea, C-13. May repeat for multiple part products.

Applicant - DXS DEVICES
The firm name holding legal responsibility for Pylori-chek Breath Test. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020900
The FDA assigned number to Pylori-chek Breath Test. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Pylori-chek Breath Test. 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 - Feb 4, 1999
The date Pylori-chek Breath Test 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 Pylori-chek Breath Test. 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 Pylori-chek Breath Test is in. Format is RX, OTC, DISCN.

Applicant Full Name - Diagnostics And Devices Inc
The full name of the firm holding legal responsibility for the new application of Pylori-chek Breath Test.

Pylori-chek Breath Test