FDA Orange Book · active-ingredient family
Ciprofloxacin hydrochloride
Ciprofloxacin hydrochloride is approved as 5 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CETRAXAL · NDA 021918
5
Brand (NDA)
28
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · ointment, solution/drops, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CETRAXALRLD | LAB SALVAT | NDA 021918 | AB | May 01, 2009 | |
| CILOXANRLD | SANDOZ | NDA 020369 | — | Mar 30, 1998 | |
| CILOXANRLD | SANDOZ | NDA 019992 | AT | Dec 31, 1990 | |
| CIPRORLD×3 | BAYER HLTHCARE | NDA 019537 | AB | Oct 22, 1987 | |
| PROQUIN XR | DEPOMED INC | NDA 021744 | — | May 19, 2005 |
Generic (ANDA) products (28)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CIPROFLOXACIN HYDROCHLORIDE | ALEMBIC THERAP | ANDA 217887 | AB | Nov 05, 2024 | |
| CIPROFLOXACIN HYDROCHLORIDE×2 | YILING | ANDA 208921 | AB | Jun 22, 2018 | |
| CIPROFLOXACIN HYDROCHLORIDE | ALTAIRE PHARMS INC | ANDA 204613 | AT | May 03, 2018 | |
| CIPROFLOXACIN HYDROCHLORIDE | PHARMOBEDIENT | ANDA 076555 | — | Dec 11, 2008 | |
| CIPROFLOXACIN HYDROCHLORIDE | FDC LTD | ANDA 077568 | AT | Jun 30, 2008 | |
| CIPROFLOXACIN HYDROCHLORIDE | AMRING PHARMS | ANDA 078598 | — | Jan 16, 2008 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | AUROBINDO PHARMA | ANDA 077859 | AB | Apr 26, 2007 | |
| CIPROFLOXACIN HYDROCHLORIDE | RISING | ANDA 077689 | AT | Dec 13, 2006 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | PLIVA | ANDA 076426 | — | Jun 15, 2005 | |
| CIPROFLOXACIN HYDROCHLORIDE | WATSON LABS INC | ANDA 076673 | AT | Jan 21, 2005 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | CHARTWELL | ANDA 076896 | AB | Nov 04, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | TARO | ANDA 076912 | — | Oct 06, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | UNIQUE | ANDA 076639 | AB | Sep 10, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE | RUBICON RESEARCH | ANDA 075928 | AT | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE | THE J MOLNER | ANDA 076754 | — | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | AIPING PHARM INC | ANDA 076593 | AB | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | AMNEAL | ANDA 075939 | — | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | BARR | ANDA 074124 | — | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | CARLSBAD | ANDA 076126 | AB | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | DR REDDYS LABS LTD | ANDA 075593 | AB | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | HIKMA | ANDA 076558 | AB | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | IVAX SUB TEVA PHARMS | ANDA 076089 | AB | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | NATCO | ANDA 075685 | — | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | NOSTRUM LABS | ANDA 076138 | — | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | RISING | ANDA 075817 | — | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | SUN PHARM INDS LTD | ANDA 075747 | — | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | TEVA | ANDA 076136 | — | Jun 09, 2004 | |
| CIPROFLOXACIN HYDROCHLORIDE×3 | WATSON LABS | ANDA 076794 | AB | Jun 09, 2004 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Ciprofloxacin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
