FDA Orange Book · active-ingredient family
Ciprofloxacin; ciprofloxacin hydrochloride
Ciprofloxacin; ciprofloxacin hydrochloride is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CIPRO XR · NDA 021473
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CIPRO XR×2 | BAYER HLTHCARE | NDA 021473 | — | Dec 13, 2002 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CIPROFLOXACIN EXTENDED RELEASE×2 | ANI PHARMS | ANDA 077809 | — | Nov 30, 2010 | |
| CIPROFLOXACIN EXTENDED RELEASE | FOSUN PHARMA | ANDA 078712 | — | Dec 11, 2007 | |
| CIPROFLOXACIN EXTENDED RELEASE×2 | PH HEALTH | ANDA 078166 | — | Nov 27, 2007 | |
| CIPROFLOXACIN EXTENDED RELEASE×2 | DR REDDYS LABS LTD | ANDA 077701 | — | Oct 31, 2007 | |
| CIPROFLOXACIN EXTENDED RELEASE×2 | RISING | ANDA 078183 | — | Mar 22, 2007 |
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; ciprofloxacin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
