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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204636
Company: RISING

Products on ANDA 204636

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	No
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204636

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204636Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 204636

ROPIVACAINE HYDROCHLORIDE

SOLUTION;INJECTION; 200MG/100ML (2MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAROPIN	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	020533	FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	216605	AMNEAL
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	205612	EUGIA PHARMA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	210102	GLAND PHARMA LTD
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	206166	INFORLIFE
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	206091	MYLAN LABS LTD
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	204636	RISING

SOLUTION;INJECTION; 400MG/200ML (2MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAROPIN	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	020533	FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	216605	AMNEAL
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	210102	GLAND PHARMA LTD
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	206166	INFORLIFE
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	206091	MYLAN LABS LTD
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	204636	RISING

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