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Last Updated: November 12, 2024

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, Purepac Pharm, Pvt Form, Roxane, Strides Pharma, 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 seven suppliers. Additional details are available on the TETRACYCLINE HYDROCHLORIDE profile page.

The generic ingredient in TETRACYCLINE HYDROCHLORIDE is tetracycline hydrochloride. There are ninety-nine drug master file entries for this compound. Eight 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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