Application 020533

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	20MG/10ML (2MG/ML)	Yes	No
002	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	40MG/20ML (2MG/ML)	Yes	No
003	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/20ML (5MG/ML)	Yes	No
004	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/20ML (7.5MG/ML)	Yes	No
005	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/10ML (10MG/ML)	Yes	No
006	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/100ML (2MG/ML)	Yes	No
007	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	400MG/200ML (2MG/ML)	Yes	No
008	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/30ML (5MG/ML)	Yes	No
009	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	500MG/100ML (5MG/ML)	Yes	No
010	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	1GM/200ML (5MG/ML)	Yes	No
011	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/20ML (10MG/ML)	Yes	Yes
012	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	75MG/10ML (7.5MG/ML)	No	No
013	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	50MG/10ML (5MG/ML)	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9924	NAROPIN	ropivacaine hydrochloride	Henry Schein, Inc.	NDA	Current
52584-286	NAROPIN	ropivacaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-286	NAROPIN	ropivacaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-286	NAROPIN	ropivacaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-286	NAROPIN	ropivacaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72129	SUPPL	2022-09-21
71477	SUPPL	2022-06-29
71343	SUPPL	2022-06-16
71335	SUPPL	2022-06-16
57659	ORIG	2019-02-15
56351	SUPPL	2018-11-08
56264	SUPPL	2018-11-05
52705	SUPPL	2018-02-23
2681	SUPPL	2014-10-30
34789	SUPPL	2013-01-07
34790	SUPPL	2012-11-15
34788	SUPPL	2010-02-25
25129	SUPPL	2010-02-25
12691	SUPPL	2010-02-25
2680	SUPPL	2010-02-25
25128	SUPPL	2006-08-11
34787	SUPPL	2006-08-09
12690	SUPPL	2004-08-12
2679	SUPPL	2004-08-12
41417	SUPPL	2004-06-28

Application 020533

Related Records#

Application Products#

NDC Listings For This Application#

Documents#