Ciprofloxacin Hydrochloride

ANDA 76673, held by Watson Labs Inc. Ciprofloxacin Hydrochloride.

As of Nov 15, 2026, ANDA 76673 (Ciprofloxacin Hydrochloride), held by Watson Labs Inc, was first approved by FDA on Jan 21, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 21, 2005
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 21, 2005	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ciprofloxacin HydrochlorideEQ 0.3% BASE · solution/drops;ophthalmic	Ciprofloxacin Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Apr 20, 2007	Supplement 2Labeling	Approved	None posted
Jan 21, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76673
Drugs@FDA: Overview at FDA
Company: Watson 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