Cipro

Treats skin and skin structure infections caused by Escherichia coli, Klebsiella…. NDA 20780, held by Bayer Hlthcare. Ciprofloxacin.

As of Nov 14, 2026, NDA 20780 (Cipro), held by Bayer Hlthcare, was first approved by FDA on Sep 26, 1997, with 45 approved supplements and 0 published complete response letters.

First approved: Sep 26, 1997
Review: Standard
Supplements approved: 45
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:

Skin and Skin Structure Infections
Bone and Joint Infections
Complicated Intra-Abdominal Infections
Infectious Diarrhea
Typhoid Fever (Enteric Fever)
Uncomplicated Cervical and Urethral Gonorrhea
Inhalational Anthrax post-exposure in adult and pediatric patients
Plague in adult and pediatric patients
Chronic Bacterial Prostatitis
Lower Respiratory Tract Infections
Acute Exacerbation of Chronic Bronchitis
Urinary Tract Infections
Urinary Tract Infections (UTI)
Acu…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 46 submissions below


Feb 2, 2015	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 7, 2005	Supplement 16Efficacy (new indication or use)	Approved	Label Letter
Mar 25, 2004	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Aug 30, 2000	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label Review
Sep 26, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Cipro250MG/5ML · for suspension;oral	Ciprofloxacin	RxReference drug
Cipro500MG/5ML · for suspension;oral	Ciprofloxacin	RxReference drug

All 46 submissions, including labeling and manufacturing supplements


Sep 20, 2024	Supplement 50Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 30, 2021	Supplement 49Labeling · Standard review	Approved	Label Letter
May 8, 2020	Supplement 48Labeling · Standard review	Approved	Label Letter
Mar 5, 2020	Supplement 47Labeling · Standard review	Approved	Label Letter
May 3, 2019	Supplement 46Labeling · Standard review	Approved	Label Letter
Oct 18, 2018	Supplement 45Labeling · Standard review	Approved	Letter Label
Jul 26, 2017	Supplement 44Labeling · Standard review	Approved	Letter Label
Sep 14, 2016	Supplement 42Labeling · Standard review	Approved	Label Letter
Jul 26, 2016	Supplement 43Labeling · Standard review	Approved	Letter Label
Feb 2, 2015	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 14, 2013	Supplement 40Labeling	Approved	Letter Label
Jan 30, 2013	Supplement 39Labeling · Standard review	Approved	Label Letter
Nov 15, 2011	Supplement 32Labeling	Approved	Letter Label
Oct 18, 2011	Supplement 38Labeling	Approved	Label Letter
Aug 3, 2011	Supplement 37REMS	Approved	Letter
Jun 10, 2011	Supplement 36Labeling · Standard review	Approved	Letter Label
Feb 25, 2011	Supplement 33Labeling	Approved	Label Letter
Jun 24, 2009	Supplement 29Labeling · Standard review	Approved	Letter
Apr 27, 2009	Supplement 28Labeling · Standard review	Approved	Label Letter
Apr 6, 2009	Supplement 30Labeling · Standard review	Approved	Label Letter
Feb 13, 2009	Supplement 27Labeling · Standard review	Approved	Label Letter
Oct 3, 2008	Supplement 26Labeling · Standard review	Approved	Label Letter
Jan 18, 2008	Supplement 25Labeling · Standard review	Approved	Label Letter
Jun 25, 2007	Supplement 24Labeling · Standard review	Approved	Letter Label
Jun 19, 2006	Supplement 23Labeling · Standard review	Approved	Letter
Nov 9, 2005	Supplement 20Labeling · Standard review	Approved	Review Letter Label
May 18, 2005	Supplement 19Labeling · Standard review	Approved	Letter Label
Jan 7, 2005	Supplement 16Efficacy (new indication or use)	Approved	Label Letter
Jul 14, 2004	Supplement 18Labeling · Standard review	Approved	Review Label Letter
Jul 14, 2004	Supplement 17Labeling · Standard review	Approved	Review Letter Label
Mar 25, 2004	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Mar 15, 2004	Supplement 15Labeling · Standard review	Approved	Review Label Letter
Mar 15, 2004	Supplement 14Labeling · Standard review	Approved	Review Label Letter
Mar 15, 2004	Supplement 12Labeling · Standard review	Approved	Review Label Letter
Apr 17, 2002	Supplement 11Labeling · Standard review	Approved	Review Label Letter
Aug 30, 2000	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label Review
Jun 28, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Jun 28, 2000	Supplement 9Labeling · Standard review	Approved	None posted
Jun 28, 2000	Supplement 7Labeling · Standard review	Approved	None posted
Jun 28, 2000	Supplement 6Labeling · Standard review	Approved	None posted
Mar 5, 1999	Supplement 5Labeling · Standard review	Approved	None posted
Sep 17, 1998	Supplement 4Labeling · Standard review	Approved	None posted
Sep 17, 1998	Supplement 3Labeling · Standard review	Approved	Review
Sep 17, 1998	Supplement 2Labeling	Approved	Review
Sep 17, 1998	Supplement 1Labeling · Standard review	Approved	Review
Sep 26, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20780
Drugs@FDA: Overview at FDA
Company: Bayer 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