Last Updated: September 28, 2026

Details for New Drug Application (NDA): 203955

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NDA 203955 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Amneal, Anthea Pharma, Caplin, Eugia Pharma, Gland, Hikma, Hospira, Inforlife, Kindos, Mylan Labs Ltd, Navinta Llc, Rising, and Somerset Theraps Llc, and is included in sixteen NDAs. It is available from eighteen suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

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

Summary for 203955

Tradename:	ROPIVACAINE HYDROCHLORIDE
Applicant:	Rising
Ingredient:	ropivacaine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	150MG/30ML (5MG/ML)
Approval Date:	Apr 11, 2016	TE:	AP	RLD:	No

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