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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 Hikma Farmaceutica, Hospira, Claris, Lupin Ltd, Teva Pharms Usa, Fresenius Kabi Usa, Bedford Labs, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Sandoz, Anchen Pharms, Mylan Pharms Inc, 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, Watson Labs, Apotex, Pharmaforce, Bedford, Teva Pharms, Acs Dobfar Info Sa, and Baxter Hlthcare, and is included in forty-seven NDAs. It is available from five 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. Sixty-eight suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for NDA: 200563

Tradename:
CIPROFLOXACIN
Applicant:
Lupin Ltd
Ingredient:
ciprofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

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) * 100 mL in 1 BOTTLE * 74 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

Summary for product number 001

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

Summary for product number 002

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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