Breathtek Ubt For H-pylori

   
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Breathtek Ubt For H-pylori


Drug - Breathtek Ubt For H-pylori
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 - EQ 75MG /POUCHE
The potency of the active ingredient(s), Urea, C-13. May repeat for multiple part products.

Applicant - MERETEK
The firm name holding legal responsibility for Breathtek Ubt For H-pylori. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020586
The FDA assigned number to Breathtek Ubt For H-pylori. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Breathtek Ubt For H-pylori. 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 - May 10, 2001
The date Breathtek Ubt For H-pylori 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 Breathtek Ubt For H-pylori. 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 Breathtek Ubt For H-pylori is in. Format is RX, OTC, DISCN.

Applicant Full Name - Meretek Diagnostics Inc
The full name of the firm holding legal responsibility for the new application of Breathtek Ubt For H-pylori.

Breathtek Ubt For H-pylori