Ciprofloxacin In Dextrose 5% In Plastic Container

ANDA 78024, held by Baxter Hlthcare Corp. Ciprofloxacin.

As of Nov 15, 2026, ANDA 78024 (Ciprofloxacin In Dextrose 5% In Plastic Container), held by Baxter Hlthcare Corp, was first approved by FDA on Mar 18, 2008, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 18, 2008
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Mar 18, 2008	Original application	Approved	Letter

Products

2 strengths and forms


Ciprofloxacin In Dextrose 5% In Plastic Container200MG/100ML · injectable;injection	Ciprofloxacin	Discontinued
Ciprofloxacin In Dextrose 5% In Plastic Container400MG/200ML · injectable;injection	Ciprofloxacin	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Sep 20, 2024	Supplement 40Labeling · Standard review	Approved	None posted
Sep 9, 2024	Supplement 35Labeling · Standard review	Approved	None posted
Sep 9, 2024	Supplement 31Labeling · Standard review	Approved	None posted
May 6, 2019	Supplement 30Labeling · Standard review	Approved	None posted
May 6, 2019	Supplement 29Labeling · Standard review	Approved	None posted
Oct 18, 2018	Supplement 25Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 21Labeling · Standard review	Approved	None posted
Jan 27, 2017	Supplement 19Labeling · Standard review	Approved	None posted
Jan 27, 2017	Supplement 18Labeling · Standard review	Approved	None posted
Jun 7, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Jun 7, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Jun 7, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Sep 18, 2012	Supplement 9Labeling · Standard review	Approved	None posted
May 21, 2012	Supplement 8Labeling	Approved	None posted
May 16, 2011	Supplement 7Labeling	Approved	None posted
Jan 26, 2010	Supplement 4Labeling	Approved	None posted
May 26, 2009	Supplement 3Labeling	Approved	None posted
Jan 29, 2009	Supplement 2Labeling	Approved	None posted
Mar 18, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 78024
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters