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Generated: April 30, 2017

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Details for New Drug Application (NDA): 062540

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NDA 062540 describes TETRACYCLINE HYDROCHLORIDE, which is a drug marketed by Warner Chilcott, Abbott, Watson Labs, Ivax Sub Teva Pharms, Roxane, Alpharma Us Pharms, Sun Pharm Inds, Superpharm, Proter, Heather, Chartwell Cienca, Elkins Sinn, Hikma Pharms Llc, Impax Labs, Idt Australia Ltd, Valeant Pharm Intl, Ferrante, Mylan, Mast Mm, Wyeth Ayerst, Pvt Form, and Purepac Pharm, and is included in twenty-six NDAs. It is available from thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.

Summary for NDA: 062540

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength250MG
Approval Date:Mar 21, 1985TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength500MG
Approval Date:Mar 21, 1985TE:RLD:No

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