Application 009435

Type: NDA
Sponsor: FRESENIUS KABI USA

Related Records

Company: FRESENIUS KABI USA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NESACAINE	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	Yes	Yes
002	NESACAINE	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	Yes	No
003	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No
004	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	3%	No	No
006	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	Yes	Yes
007	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	3%	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9926	Nesacaine	Chloroprocaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9926	Nesacaine	Chloroprocaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9927	NESACAINE	chloroprocaine hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9927	NESACAINE	chloroprocaine hydrochloride	Henry Schein, Inc.	NDA	Current
51662-1401	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1401	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1401	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1407	(CHLOROPROCAINE HCI	(CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1407	(CHLOROPROCAINE HCI	(CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1407	(CHLOROPROCAINE HCI	(CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1408	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1408	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1408	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1408	CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-475	Nesacaine	Chloroprocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-476	NESACAINE	chloroprocaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
63323-475	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-475	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-475	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-476	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-476	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-476	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-477	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-477	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-477	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-478	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-478	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-478	Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current

Documents

Document	Submission type	Date
56313	SUPPL	2018-11-06
56257	SUPPL	2018-11-05
11879	SUPPL	2010-03-18
192	SUPPL	2010-03-18
33004	SUPPL	2010-02-25
10729	SUPPL	2010-02-25
11878	SUPPL	2004-06-23
33003	SUPPL	2004-06-22