CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

FDA-2014-P-1753 · 7 docket documents

Angela A. Stanton, Ph.D. filed this citizen petition on October 27, 2014, requesting that the FDA restrict ciprofloxacin (Cipro), approved under NDAs 19-537, 19-847, 19-857, and 20-780, to life-threatening situations only and limit its availability to emergency rooms, surgical procedures, and intens

FDA-2012-P-0647 · 3 docket documents

Laboratorios SALVAT, S.A., through Fish & Richardson P.C., filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any abbreviated new drug applications for non-sterile otic formulations citing CETRAXAL (ciprofloxacin hydroc

FDA-2004-P-0481 · 6 docket documents

Stradling Yocca Carlson and Rauth filed this citizen petition pursuant to 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting authorization to submit an abbreviated new drug application (ANDA) for a preservative-free Ciprofloxacin HCL ophthalmic solution in 0.4 mL unit dose containers

FDA-2007-P-0014 · 4 docket documents

JRRapoza Associates, Inc. submitted this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA determination that Ciprofloxacin Hydrochloride Capsules in 100mg, 250mg, 500mg, and 750mg strengths are suitable for filing an Abbreviated New Drug Appli

FDA-2005-P-0064 · 6 docket documents

The Office of the Illinois Attorney General, filed this citizen petition on May 18, 2005, requesting that the FDA require manufacturers of fluoroquinolone antibiotics (ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin, and moxifloxacin) to strengthen labeling warnings about tendonopathy and tendo