Is there a generic for Ciprofloxacin; dexamethasone?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Ciprofloxacin; dexamethasone, referencing the brand CIPRODEX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ciprofloxacin; dexamethasone?

CIPRODEX (NDA 021537, SANDOZ) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ciprofloxacin; dexamethasone are approved?

Ciprofloxacin; dexamethasone is approved in the following dosage form: suspension/drops.

FDA Orange Book · active-ingredient family

Ciprofloxacin; dexamethasone

Ciprofloxacin; dexamethasone 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:CIPRODEX · NDA 021537

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · suspension/drops

Product	Applicant	Application	TE	Approved
CIPRODEXRLD	SANDOZ	NDA 021537	AB	Jul 18, 2003

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
CIPROFLOXACIN AND DEXAMETHASONE	UPSHER SMITH LABS	ANDA 216487	AB	Jan 06, 2026
CIPROFLOXACIN AND DEXAMETHASONE	AMNEAL	ANDA 216501	AB	Mar 22, 2024
CIPROFLOXACIN AND DEXAMETHASONE	SENTISS	ANDA 215768	AB	Jun 09, 2023
CIPROFLOXACIN AND DEXAMETHASONE	SUN PHARM	ANDA 210470	AB	Aug 30, 2022
CIPROFLOXACIN AND DEXAMETHASONE	DR REDDYS	ANDA 205548	AB	Aug 10, 2020

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; dexamethasone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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