Orange Book product · Generic (ANDA)
CIPROFLOXACIN AND DEXAMETHASONE
CIPROFLOXACIN; DEXAMETHASONE
At a glance
Aug 10, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 10, 2020
5 yr 11 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 205548
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
- 2024CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 216501 · AMNEAL
- 2023CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 215768 · SENTISS
- 2022CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 210470 · SUN PHARM
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.
