Ciprofloxacin

ANDA 77782, held by Dr Reddys. Ciprofloxacin.

As of Nov 15, 2026, ANDA 77782 (Ciprofloxacin), held by Dr Reddys, was first approved by FDA on Aug 28, 2006, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2006
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 28, 2006	Original application	Approved	Letter

Products

2 strengths and forms


Ciprofloxacin200MG/20ML (10MG/ML) · injectable;injection	Ciprofloxacin	Discontinued
Ciprofloxacin400MG/40ML (10MG/ML) · injectable;injection	Ciprofloxacin	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Sep 20, 2024	Supplement 21Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 20Labeling · Standard review	Approved	None posted
Apr 26, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Apr 26, 2019	Supplement 18Labeling · Standard review	Approved	None posted
Apr 26, 2019	Supplement 19Labeling · Standard review	Approved	None posted
Oct 18, 2018	Supplement 17Labeling · Standard review	Approved	None posted
Jun 30, 2014	Supplement 15Labeling · Standard review	Approved	None posted
Jun 23, 2011	Supplement 8Labeling	Approved	None posted
Oct 5, 2009	Supplement 3Labeling	Approved	None posted
Jan 29, 2009	Supplement 2Labeling	Approved	None posted
Aug 28, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77782
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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