Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216501
Company: AMNEAL

Products on ANDA 216501

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216501

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216501

CIPROFLOXACIN; 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	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; DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	216501	AMNEAL