Details for New Drug Application (NDA): 020533

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NDA 020533 describes NAROPIN, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NAROPIN profile page.

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

Summary for 020533

Tradename:	NAROPIN
Applicant:	Fresenius Kabi Usa
Ingredient:	ropivacaine hydrochloride
Patents:	4
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020533

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 020533

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533	NDA	General Injectables & Vaccines, Inc	52584-286	52584-286-35	1 VIAL, SINGLE-DOSE in 1 BAG (52584-286-35) > 30 mL in 1 VIAL, SINGLE-DOSE
NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533	NDA	Fresenius Kabi USA, LLC	63323-285	63323-285-67	100 mL in 1 BOTTLE (63323-285-67)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	20MG/10ML (2MG/ML)
Approval Date:	May 1, 1998	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	40MG/20ML (2MG/ML)
Approval Date:	Sep 24, 1996	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	100MG/20ML (5MG/ML)
Approval Date:	May 1, 1998	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020533

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998	➤ Sign Up	➤ Sign Up
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	➤ Sign Up	➤ Sign Up
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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