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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 050404

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NDA 050404 describes AUREOMYCIN, which is a drug marketed by Lederle and is included in one NDA. Additional details are available on the AUREOMYCIN profile page.

The generic ingredient in AUREOMYCIN is chlortetracycline hydrochloride. There are twelve drug master file entries for this compound. Additional details are available on the chlortetracycline hydrochloride profile page.

Summary for 050404

Tradename:	AUREOMYCIN
Applicant:	Lederle
Ingredient:	chlortetracycline hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 050404

Anti-Bacterial Agents
Antiprotozoal Agents
Protein Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;OPHTHALMIC			Strength	1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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