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Serving leading biopharmaceutical companies globally:

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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075817

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NDA 075817 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, Hikma, Idt Australia Ltd, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sandoz, 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-two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for 075817

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

Pharmacology for NDA: 075817

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 075817

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075817 ANDA Mylan Pharmaceuticals Inc. 0378-7098 0378-7098-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7098-01)
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075817 ANDA Blenheim Pharmacal, Inc. 10544-605 10544-605-06 6 TABLET, FILM COATED in 1 BOTTLE (10544-605-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jun 25, 2007TE:ABRLD:No

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


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Citi
Queensland Health
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QuintilesIMS
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US Department of Justice
Chinese Patent Office

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