Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205548
Company: DR REDDYS

Products on ANDA 205548

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205548

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/10/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205548Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205548

CIPROFLOXACIN AND DEXAMETHASONE

SUSPENSION/DROPS;OTIC; 0.3%;0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIPRODEX	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	Yes	AB	021537	SANDOZ
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	216501	AMNEAL
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	205548	DR REDDYS
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	215768	SENTISS
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	210470	SUN PHARM
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	216487	UPSHER SMITH LABS