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Details for New Drug Application (NDA): 077417

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NDA 077417 describes CIPROFLOXACIN EXTENDED RELEASE, which is a drug marketed by Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Sandoz, Anchen Pharms, and Mylan Pharms Inc, and is included in six NDAs. It is available from four suppliers. Additional details are available on the CIPROFLOXACIN EXTENDED RELEASE profile page.

The generic ingredient in CIPROFLOXACIN EXTENDED RELEASE is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.

Summary for NDA: 077417

Tradename:
CIPROFLOXACIN EXTENDED RELEASE
Applicant:
Actavis Labs Fl Inc
Ingredient:
ciprofloxacin; ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 077417

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 077417

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN EXTENDED RELEASE
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 077417 ANDA Watson Pharma, Inc. 62037-942 62037-942-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-942-01)
CIPROFLOXACIN EXTENDED RELEASE
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 077417 ANDA Watson Pharma, Inc. 62037-942 62037-942-06 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-942-06)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength212.6MG;EQ 287.5MG BASE
Approval Date:Nov 30, 2010TE:RLD:No


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