Last Updated: November 8, 2026

Details for New Drug Application (NDA): 050493

NDA 050493 describes TOPICYCLINE, which is a drug marketed by Shire and is included in one NDA. Additional details are available on the TOPICYCLINE profile page.

The generic ingredient in TOPICYCLINE 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 050493

Tradename:	TOPICYCLINE
Applicant:	Shire
Ingredient:	tetracycline hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;TOPICAL			Strength	2.2MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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