Last Updated: September 24, 2026

Details for New Drug Application (NDA): 060760

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NDA 060760 describes OXYTETRACYCLINE HYDROCHLORIDE, which is a drug marketed by Hikma, Impax Labs, Proter, and Purepac Pharm, and is included in four NDAs. Additional details are available on the OXYTETRACYCLINE HYDROCHLORIDE profile page.

The generic ingredient in OXYTETRACYCLINE HYDROCHLORIDE is oxytetracycline hydrochloride. There is one drug master file entry for this compound. Additional details are available on the oxytetracycline hydrochloride profile page.

Summary for 060760

Tradename:	OXYTETRACYCLINE HYDROCHLORIDE
Applicant:	Impax Labs
Ingredient:	oxytetracycline hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 250MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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