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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076126

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NDA 076126 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Taro Pharm, Mylan, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Sun Pharm Inds Ltd, Teligent, Akorn Inc, Hikma, Aurobindo Pharma, Fdc Ltd, Watson Labs Inc, Rising Pharms Inc, Ivax Sub Teva Pharms, Dr Reddys Labs Ltd, Sandoz, Watson Labs, Apotex, and Amring Pharms, 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-two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for NDA: 076126

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 076126

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 076126

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL 076126 ANDA KAISER FOUNDATION HOSPITALS 0179-0054 0179-0054-14 14 TABLET, FILM COATED in 1 BOTTLE (0179-0054-14)
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL 076126 ANDA KAISER FOUNDATION HOSPITALS 0179-0054 0179-0054-20 20 TABLET, FILM COATED in 1 BOTTLE (0179-0054-20)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jun 9, 2004TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jun 9, 2004TE:ABRLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 750MG BASE
Approval Date:Jun 9, 2004TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

UBS
McKinsey
Mallinckrodt
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US Department of Justice
Harvard Business School
Cantor Fitzgerald
Farmers Insurance
Julphar
Fish and Richardson

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