Details for New Drug Application (NDA): 020900

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NDA 020900 describes PYLORI-CHEK BREATH TEST, which is a drug marketed by Dxs Devices and is included in one NDA. Additional details are available on the PYLORI-CHEK BREATH TEST profile page.

The generic ingredient in PYLORI-CHEK BREATH TEST is urea c-13. There are thirty-three drug master file entries for this compound. Additional details are available on the urea c-13 profile page.

Summary for 020900

Tradename:	PYLORI-CHEK BREATH TEST
Applicant:	Dxs Devices
Ingredient:	urea c-13
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	100MG/VIAL
Approval Date:	Feb 4, 1999	TE:		RLD:	No

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