Orange Book product · Generic (ANDA)
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
At a glance
Nov 10, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 10, 2025
7 mo ago
Exclusivity ends · CGT
FDA marketing exclusivity
Jun 02, 2026
17 d ago
Today
Pharmaceutical detail
Active ingredient
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
Strength
EQ 0.2% BASE;1%
Dosage form
SUSPENSION/DROPS
Route
OTIC
TE code
AB
Application
ANDA 218273
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
Jun 02, 2026
17 d ago
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.
