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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217887
Company: NEW HEIGHTSRX

Products on ANDA 217887

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS;OTIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217887

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217887

CIPROFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OTIC; EQ 0.2% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CETRAXAL	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS;OTIC	Prescription	Yes	AB	021918	LAB SALVAT
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS;OTIC	Prescription	No	AB	217887	NEW HEIGHTSRX

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