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Generated: December 12, 2018

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Details for New Drug Application (NDA): 204613

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NDA 204613 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Altaire Pharms Inc, Amring Pharms, Anda Repository, Apotex Inc, Fdc Ltd, Teligent, Watson Labs Inc, Ani Pharms Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, and Yiling Pharm Ltd, and is included in twenty-seven NDAs. It is available from sixty-eight 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. Seventy-five suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 204613
Tradename:CIPROFLOXACIN HYDROCHLORIDE
Applicant:Altaire Pharms Inc
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204613
Suppliers and Packaging for NDA: 204613
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 204613 ANDA Altaire Pharmaceuticals Inc. 59390-217 59390-217-02 2.5 mL in 1 BOTTLE, PLASTIC (59390-217-02)
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 204613 ANDA Altaire Pharmaceuticals Inc. 59390-217 59390-217-05 5 mL in 1 BOTTLE, PLASTIC (59390-217-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:May 3, 2018TE:ATRLD:No

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