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Harvard Business School
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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 060704

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NDA 060704 describes TETRACYCLINE HYDROCHLORIDE, which is a drug marketed by Abbott, Chartwell Tetra, Elkins Sinn, Ferrante, Heather, Hikma Pharms, Idt Australia Ltd, Impax Labs, Ivax Sub Teva Pharms, Mast Mm, Mylan, 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-six NDAs. It is available from twelve 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. Fifteen suppliers are listed for this compound. Additional details are available on the tetracycline hydrochloride profile page.
Summary for 060704
Tradename:TETRACYCLINE HYDROCHLORIDE
Applicant:Ivax Sub Teva Pharms
Ingredient:tetracycline hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 060704
Ingredient-typeTetracyclines
Suppliers and Packaging for NDA: 060704
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TETRACYCLINE HYDROCHLORIDE tetracycline hydrochloride CAPSULE;ORAL 060704 ANDA Liberty Pharmaceuticals, Inc. 0440-8505 N 0440-8505-91
TETRACYCLINE HYDROCHLORIDE tetracycline hydrochloride CAPSULE;ORAL 060704 ANDA Blenheim Pharmacal, Inc. 10544-590 E 10544-590-90

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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