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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075928
Company: RUBICON

Products on ANDA 075928

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075928

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2004	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75928.ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75928ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2011	SUPPL-15	Labeling		Label is not available on this site.
04/22/2005	SUPPL-6	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075928

CIPROFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	019992	SANDOZ
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	204613	ALTAIRE PHARMS INC
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	077568	FDC LTD
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	077689	RISING
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	075928	RUBICON
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076673	WATSON LABS INC

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