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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076639

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NDA 076639 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms Inc, Teligent, Watson Labs Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Idt Australia Ltd, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, and Watson Labs, and is included in twenty-five NDAs. It is available from sixty-seven suppliers. Additional details are available on the CIPROFLOXACIN HYDROCHLORIDE profile page.

The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 076639
Tradename:CIPROFLOXACIN HYDROCHLORIDE
Applicant:Unique Pharm Labs
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076639
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 076639
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076639 ANDA Blenheim Pharmacal, Inc. 10544-079 E 10544-079-06
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076639 ANDA Blenheim Pharmacal, Inc. 10544-079 E 10544-079-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Sep 10, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Sep 10, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 750MG BASE
Approval Date:Sep 10, 2004TE:ABRLD:No

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