Ciprofloxacin Hydrochloride

ANDA 76912, held by Taro. Ciprofloxacin Hydrochloride.

As of Nov 15, 2026, ANDA 76912 (Ciprofloxacin Hydrochloride), held by Taro, was first approved by FDA on Oct 6, 2004, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 6, 2004
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 6, 2004	Original application	Approved	None posted

Products

3 strengths and forms


Ciprofloxacin HydrochlorideEQ 250MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Discontinued
Ciprofloxacin HydrochlorideEQ 500MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Discontinued
Ciprofloxacin HydrochlorideEQ 750MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 1, 2012	Supplement 6Labeling	Approved	None posted
May 18, 2011	Supplement 5Labeling	Approved	None posted
Jul 23, 2009	Supplement 4Labeling	Approved	None posted
Jan 29, 2009	Supplement 3Labeling	Approved	None posted
Feb 18, 2005	Supplement 1Labeling	Approved	None posted
Oct 6, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76912
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceuticals

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