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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077859

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NDA 077859 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-eight 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-four suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for 077859

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

Pharmacology for NDA: 077859

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 077859

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 077859 ANDA Aurolife Pharma LLC 13107-076 13107-076-30 30 TABLET, FILM COATED in 1 BOTTLE (13107-076-30)
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 077859 ANDA Aurolife Pharma LLC 13107-076 13107-076-01 100 TABLET, FILM COATED in 1 BOTTLE (13107-076-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Apr 26, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Apr 26, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 750MG BASE
Approval Date:Apr 26, 2007TE:ABRLD:No


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