Last Updated: November 8, 2026

Details for New Drug Application (NDA): 061471

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NDA 061471 describes TETRACYCLINE HYDROCHLORIDE, which is a drug marketed by Abbott, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Chartwell Tetra, Elkins Sinn, Ferrante, Heather, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mast Mm, Novitium Pharma, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Valeant Pharm Intl, Warner Chilcott, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, and Proter, and is included in twenty-nine NDAs. It is available from nine suppliers. Additional details are available on the TETRACYCLINE HYDROCHLORIDE profile page.

The generic ingredient in TETRACYCLINE HYDROCHLORIDE 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 061471

Tradename:	TETRACYCLINE HYDROCHLORIDE
Applicant:	Ani Pharms
Ingredient:	tetracycline hydrochloride
Patents:	0

Profile for product number 001

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

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