Last Updated: September 24, 2026

Details for New Drug Application (NDA): 050653

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NDA 050653 describes ACTISITE, which is a drug marketed by Schiff And Co and is included in one NDA. Additional details are available on the ACTISITE profile page.

The generic ingredient in ACTISITE is tetracycline hydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.

Summary for 050653

Tradename:	ACTISITE
Applicant:	Schiff And Co
Ingredient:	tetracycline hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FIBER, EXTENDED RELEASE;PERIODONTAL			Strength	12.7MG/FIBER
Approval Date:	Mar 25, 1994	TE:		RLD:	No

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