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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078601

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NDA 078601 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Amneal, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Inforlife, Kindos, Mylan Labs Ltd, Navinta Llc, Rising, and Somerset Theraps Llc, and is included in fifteen NDAs. It is available from twelve suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

Summary for 078601

Tradename:	ROPIVACAINE HYDROCHLORIDE
Applicant:	Navinta Llc
Ingredient:	ropivacaine hydrochloride
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	150MG/30ML (5MG/ML)
Approval Date:	Jul 17, 2014	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	200MG/20ML (10MG/ML)
Approval Date:	Jul 17, 2014	TE:	AP	RLD:	No

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