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Pylori-chek Breath TestDrug - Pylori-chek Breath Test The trade name of the product as shown on the labeling.
Dosage -
FOR SOLUTION; ORAL
Active Ingredient(s) -
Urea, C-13
Strength -
100MG/VIAL
Applicant -
DXS DEVICES
New Drug Application (NDA) Number -
020900
Product Number -
001
Therapeutic Equivalence (TE) Code -
Approval Date -
Feb 4, 1999
Reference Listed Drug (RLD) -
No
Type -
DISCN
Applicant Full Name -
Diagnostics And Devices Inc
Pylori-chek Breath Test
Breathtek Ubt For H-pylori Eq 75mg /pouche For Solution; Oral
Helicosol 125mg/vial For Solution; Oral Meretek Ubt Kit (w/ Pranactin) 125mg/vial For Solution; Oral Pylori-chek Breath Test 100mg/vial For Solution; Oral Bilopaque 750mg Capsule; Oral Virac Rex 0.5%;1.8% Solution; Topical Rescula 0.15% Solution/drops; Ophthalmic Uracil Mustard 1mg Capsule; Oral Sterile Urea 40gm/vial Injectable; Injection Ureaphil 40gm/vial Injectable; Injection NewDrugInformation |