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Generated: October 16, 2018

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Details for New Drug Application (NDA): 200563

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NDA 200563 describes CIPROFLOXACIN, which is a drug marketed by Lupin Ltd, Baxter Hlthcare Corp, Bedford Labs, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Mylan Pharms Inc, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms, Teligent, Watson Labs Inc, Ani Pharms Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Yiling Pharm Ltd, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in forty-nine NDAs. It is available from four suppliers. Additional details are available on the CIPROFLOXACIN profile page.

The generic ingredient in CIPROFLOXACIN 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 200563
Tradename:CIPROFLOXACIN
Applicant:Lupin Ltd
Ingredient:ciprofloxacin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 200563
Suppliers and Packaging for NDA: 200563
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN ciprofloxacin FOR SUSPENSION;ORAL 200563 ANDA Lupin Pharmaceuticals, Inc. 68180-392 68180-392-01 1 KIT in 1 KIT (68180-392-01) * 74 mL in 1 BOTTLE * 100 mL in 1 BOTTLE
CIPROFLOXACIN ciprofloxacin FOR SUSPENSION;ORAL 200563 ANDA Lupin Pharmaceuticals, Inc. 68180-393 68180-393-01 1 KIT in 1 KIT (68180-393-01) * 100 mL in 1 BOTTLE * 71 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Mar 5, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength500MG/5ML
Approval Date:Mar 5, 2014TE:ABRLD:No

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