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Details for New Drug Application (NDA): 076558

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NDA 076558 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Taro, Mylan, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Sun Pharm Inds Ltd, Teligent Pharma Inc, 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 Pharmaforce, and is included in twenty-five NDAs. It is available from sixty-four 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. Sixty-nine suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for NDA: 076558

Tradename:
CIPROFLOXACIN HYDROCHLORIDE
Applicant:
Hikma
Ingredient:
ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 076558

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 076558

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL 076558 ANDA West-ward Pharmaceutical Corp 0143-2037 0143-2037-01 100 TABLET, FILM COATED in 1 BOTTLE (0143-2037-01)
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL 076558 ANDA West-ward Pharmaceutical Corp 0143-2037 0143-2037-05 500 TABLET, FILM COATED in 1 BOTTLE (0143-2037-05)

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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