Cipro In Sodium Chloride 0.9% In Plastic Container

NDA 19858, held by Bayer Pharms. Ciprofloxacin.

As of Nov 13, 2026, NDA 19858 (Cipro In Sodium Chloride 0.9% In Plastic Container), held by Bayer Pharms, was first approved by FDA on Dec 26, 1990, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 26, 1990
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Aug 30, 2000	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Sep 24, 1998	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 24, 1998	Supplement 16Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 3, 1998	Supplement 12Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 7, 1997	Supplement 15Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 21, 1996	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 10, 1996	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 26, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cipro In Sodium Chloride 0.9% In Plastic Container200MG/100ML · injectable;injection	Ciprofloxacin	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Apr 17, 2002	Supplement 22Labeling · Standard review	Approved	Review Letter Label
Aug 30, 2000	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Jun 28, 2000	Supplement 20Labeling · Standard review	Approved	None posted
Sep 24, 1998	Supplement 19Labeling · Standard review	Approved	None posted
Sep 24, 1998	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 24, 1998	Supplement 17Labeling · Standard review	Approved	None posted
Sep 24, 1998	Supplement 16Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 3, 1998	Supplement 12Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 26, 1997	Supplement 11Labeling · Standard review	Approved	Review
Aug 7, 1997	Supplement 15Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 21, 1996	Supplement 8Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 10, 1996	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 9, 1996	Supplement 14Labeling · Standard review	Approved	None posted
Jul 9, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 25, 1995	Supplement 6Labeling · Standard review	Approved	None posted
May 13, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 23, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 24, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 24, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 26, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19858
Drugs@FDA: Overview at FDA
Company: Bayer Pharms

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