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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 202584

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NDA 202584 describes BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE, which is a drug marketed by Ailex Pharms Llc and is included in one NDA. Additional details are available on the BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE profile page.

The generic ingredient in BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is bismuth subsalicylate; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Additional details are available on the bismuth subsalicylate; metronidazole; tetracycline hydrochloride profile page.

Summary for 202584

Tradename:	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Applicant:	Ailex Pharms Llc
Ingredient:	bismuth subsalicylate; metronidazole; tetracycline hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE, TABLET, CAPSULE;ORAL			Strength	262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG
Approval Date:	Nov 30, 2018	TE:		RLD:	No

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