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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078601
Company: NAVINTA LLC

Products on ANDA 078601

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	5MG/ML(0.5%)	INJECTABLE; INJECTION	Prescription	None	No	No
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	No
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078601

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/17/2014	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078601

ROPIVACAINE HYDROCHLORIDE

SOLUTION;INJECTION; 150MG/30ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAROPIN	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	020533	FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	219883	ANTHEA PHARMA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	212808	CAPLIN
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	205612	EUGIA PHARMA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	214074	HIKMA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	218713	KINDOS
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	078601	NAVINTA LLC
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	203955	RISING
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	207636	SOMERSET THERAPS LLC

SOLUTION;INJECTION; 200MG/20ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAROPIN	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	020533	FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	219883	ANTHEA PHARMA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	212808	CAPLIN
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	205612	EUGIA PHARMA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	214074	HIKMA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	218713	KINDOS
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	078601	NAVINTA LLC
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	207636	SOMERSET THERAPS LLC

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