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Details for New Drug Application (NDA): 076754

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NDA 076754 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by 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, Dr Reddys Labs Ltd, Sandoz, Watson Labs, Apotex, and Pharmaforce, and is included in twenty-five NDAs. It is available from sixty-three 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. Sixty-eight suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

Summary for NDA: 076754

Tradename:
CIPROFLOXACIN HYDROCHLORIDE
Applicant:
Teligent Pharma Inc
Ingredient:
ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 076754

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 076754

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC 076754 ANDA Bausch & Lomb Incorporated 24208-444 24208-444-05 1 BOTTLE, DROPPER in 1 CARTON (24208-444-05) > 5 mL in 1 BOTTLE, DROPPER
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC 076754 ANDA Bausch & Lomb Incorporated 24208-444 24208-444-10 1 BOTTLE, DROPPER in 1 CARTON (24208-444-10) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:Jun 9, 2004TE:ATRLD:No


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