ANDA 78062, held by Baxter Hlthcare Corp. Ciprofloxacin.
As of Nov 15, 2026, ANDA 78062 (Ciprofloxacin), held by Baxter Hlthcare Corp, was first approved by FDA on Apr 29, 2008, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2008 | Original application | Approved | None posted |
| Ciprofloxacin200MG/20ML (10MG/ML) · injectable;injection | Ciprofloxacin | Discontinued |
| Ciprofloxacin400MG/40ML (10MG/ML) · injectable;injection | Ciprofloxacin | Discontinued |
| May 6, 2019 | Supplement 18Labeling · Standard review | Approved | None posted |
| May 6, 2019 | Supplement 17Labeling · Standard review | Approved | None posted |
| Oct 18, 2018 | Supplement 16Labeling · Standard review | Approved | None posted |
| Oct 15, 2018 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jan 27, 2017 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jan 27, 2017 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jun 7, 2016 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jun 7, 2016 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jun 7, 2016 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 26, 2012 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 24, 2012 | Supplement 7Labeling | Approved | None posted |
| May 16, 2011 | Supplement 6Labeling | Approved | None posted |
| Jan 29, 2010 | Supplement 3Labeling | Approved | None posted |
| May 26, 2009 | Supplement 2Labeling | Approved | None posted |
| Jan 29, 2009 | Supplement 1Labeling | Approved | None posted |
| Apr 29, 2008 | Original application | Approved | None posted |
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
