CIPROFLOXACIN HYDROCHLORIDE | N019537 | BAYER HEALTHCARE PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from David Melvin FDA-2023-P-4222 Linda Martin, David Melvin, and Michael Mendoza filed this citizen petition under sections 505(o)(4) and 505-1(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require all fluoroquinolone antibiotics, including Levaquin (levofloxacin, NDA 020634) and Cipro (ciprofloxacin, | Other | 2023-09-28 | Open | David Melvin |
Citizen Petition From Angela A Stanton PHD FDA-2014-P-1753 Angela A. Stanton, Ph.D. filed this citizen petition on October 27, 2014 requesting that the FDA Commissioner amend the regulation approving Cipro (ciprofloxacin) under NDAs 19-537/S-409, 19-857/S-031, 19-847/S-027, and 20-780/S-013 to restrict the drug to life-threatening situations only in emergen | Other | 2014-11-06 | Denied | Angela A Stanton PHD |
Citizen Petition From Angela A Stanton PHD FDA-2014-P-1753 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 | Other | 2014-10-29 | Denied | Angela A Stanton PHD |
Citizen Petition from JR Rapoza Associates, Inc. FDA-2007-P-0014 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100mg, 250mg, 500mg, and 750mg strengths are suitable for filing an Abbreviated New Drug Appli | Other | 2008-04-11 | Withdrawn | JR Rapoza Associates, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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