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Last Updated: July 21, 2024

Details for New Drug Application (NDA): 076992


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NDA 076992 describes CIPROFLOXACIN, which is a drug marketed by Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Sentiss, Sun Pharm, Anchen Pharms, Ani Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Rising, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rubicon, Saptalis Pharms, Watson Labs Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in fifty-two NDAs. It is available from one supplier. Additional details are available on the CIPROFLOXACIN profile page.

The generic ingredient in CIPROFLOXACIN is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 076992
Tradename:CIPROFLOXACIN
Applicant:Bedford Labs
Ingredient:ciprofloxacin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076992

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength200MG/20ML (10MG/ML)
Approval Date:Aug 28, 2006TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength400MG/40ML (10MG/ML)
Approval Date:Aug 28, 2006TE:RLD:No

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