Orange Book product · Generic (ANDA)
CIPROFLOXACIN AND DEXAMETHASONE
CIPROFLOXACIN; DEXAMETHASONE
At a glance
Mar 22, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 22, 2024
2 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CIPROFLOXACIN; DEXAMETHASONE
Strength
0.3%;0.1%
Dosage form
SUSPENSION/DROPS
Route
OTIC
TE code
AB
Application
ANDA 216501
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CIPROFLOXACIN; DEXAMETHASONE
- 2003CIPRODEXBrand (NDA)
NDA 021537 · SANDOZ
- 2026CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 216487 · UPSHER SMITH LABS
- 2023CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 215768 · SENTISS
- 2022CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 210470 · SUN PHARM
- 2020CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 205548 · DR REDDYS
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.
