Application 006488

Type: NDA
Sponsor: FRESENIUS KABI USA

Related Records

Company: FRESENIUS KABI USA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	Yes	Yes
003	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.01MG/ML;2%	No	No
004	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.01MG/ML;1%	Yes	Yes
005	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.02MG/ML;2%	Yes	Yes
007	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	Yes	Yes
008	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	Yes	Yes
010	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1.5%	Yes	Yes
012	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;0.5%	Yes	Yes
017	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;1.5%	Yes	Yes
018	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;1%	Yes	Yes
019	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.005MG/ML;2%	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9972	Xylocaine	Lidocaine Hydrochloride and epinephrine	Henry Schein, Inc.	NDA	Current
0404-9972	Xylocaine	Lidocaine Hydrochloride and epinephrine	Henry Schein, Inc.	NDA	Current
0404-9973	Xylocaine	Lidocaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9973	Xylocaine	Lidocaine Hydrochloride	Henry Schein, Inc.	NDA	Current
0404-9974	Xylocaine	Lidocaine HCl	Henry Schein, Inc.	NDA	Current
0404-9974	Xylocaine	Lidocaine HCl	Henry Schein, Inc.	NDA	Current
0404-9975	Xylocaine	Lidocaine hydrochloride, epinephrine bitartrate injection, solution	Henry Schein, Inc	NDA	Current
0404-9975	Xylocaine	Lidocaine hydrochloride, epinephrine bitartrate injection, solution	Henry Schein, Inc	NDA	Current
0404-9976	Xylocaine	Lidocaine Hydrochloride and epinephrine	Henry Schein, Inc.	NDA	Current
0404-9976	Xylocaine	Lidocaine Hydrochloride and epinephrine	Henry Schein, Inc.	NDA	Current
0404-9977	Xylocaine	Lidocaine Hydrochloride and Epinephrine	Henry Schein, Inc.	NDA	Current
0404-9977	Xylocaine	Lidocaine Hydrochloride and Epinephrine	Henry Schein, Inc.	NDA	Current
21695-466	XYLOCAINE	Lidocaine Hydrochloride	Rebel Distributors Corp	NDA	Current
49836-003	P-Care X	Lidocaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-003	P-Care X	Lidocaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-003	P-Care X	Lidocaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-016	D-Care 100X	Lidocaine Hydrochloride, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-016	D-Care 100X	Lidocaine Hydrochloride, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-016	D-Care 100X	Lidocaine Hydrochloride, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
50090-3321	Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	A-S Medication Solutions	NDA	Current
51662-1405	XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1405	XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1405	XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1412	LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1412	LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1412	LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1505	LIDOCAINE HCI AND EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1505	LIDOCAINE HCI AND EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1506	LIDOCAINE HCI AND EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1506	LIDOCAINE HCI AND EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1550	XYLOCAINE-MPF WITH EPI	XYLOCAINE-MPF WITH EPI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1550	XYLOCAINE-MPF WITH EPI	XYLOCAINE-MPF WITH EPI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1587	XYLOCAIN (LIDOCAINE HCl )	XYLOCAINE (LIDOCAINE HCl )	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1589	LIDOCAINE HCl AND EPI	LIDOCAINE HCl AND EPI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1590	Lidocaine hydrochloride	Lidocaine hydrochloride	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1591	Lidocaine hydrochloride	Lidocaine hydrochloride	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1604	XYLOCAINE- MPF (LIDOCAINE HCl )	LIDOCAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-481	Xylocaine	Lidocaine hydrochloride, epinephrine bitartrate injection, solution	General Injectables & Vaccines, Inc	NDA	Current
52584-481	Xylocaine	Lidocaine hydrochloride, epinephrine bitartrate injection, solution	General Injectables & Vaccines, Inc	NDA	Current
52584-481	Xylocaine	Lidocaine hydrochloride, epinephrine bitartrate injection, solution	General Injectables & Vaccines, Inc	NDA	Current
52584-481	Xylocaine	Lidocaine hydrochloride, epinephrine bitartrate injection, solution	General Injectables & Vaccines, Inc	NDA	Current
52584-481	Xylocaine	Lidocaine hydrochloride, epinephrine bitartrate injection, solution	General Injectables & Vaccines, Inc	NDA	Current
52584-482	Xylocaine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-482	Xylocaine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-482	Xylocaine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-482	Xylocaine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-482	Xylocaine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-482	Xylocaine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-482	Xylocaine	Lidocaine Hydrochloride and Epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-483	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-483	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-483	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-483	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-483	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-483	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-483	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-483	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-484	Xylocaine	Lidocaine Hydrochloride	General Injectables & Vac	NDA	Current
52584-484	Xylocaine	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-484	Xylocaine	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-485	Xylocaine	Lidocaine Hydrochloride	General Injectables and Vaccines, inc.	NDA	Current
52584-485	Xylocaine	Lidocaine Hydrochloride	General Injectables and Vaccines, inc.	NDA	Current
52584-485	Xylocaine	Lidocaine Hydrochloride	General Injectables and Vaccines, inc.	NDA	Current
52584-485	Xylocaine	Lidocaine Hydrochloride	General Injectables and Vaccines, inc.	NDA	Current
52584-485	Xylocaine	Lidocaine Hydrochloride	General Injectables and Vaccines, inc.	NDA	Current
52584-485	Xylocaine	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-485	Xylocaine	Lidocaine Hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-486	Xylocaine	Lidocaine HCl	General Injectables & Vaccines, Inc	NDA	Current
52584-486	Xylocaine	Lidocaine HCl	General Injectables & Vaccines, Inc	NDA	Current
52584-486	Xylocaine	Lidocaine HCl	General Injectables & Vaccines, Inc	NDA	Current
52584-486	Xylocaine	Lidocaine HCl	General Injectables & Vaccines, Inc	NDA	Current
52584-486	Xylocaine	Lidocaine HCl	General Injectables & Vaccines, Inc	NDA	Current
52584-486	Xylocaine	Lidocaine HCl	General Injectables & Vaccines, Inc	NDA	Current
52584-486	Xylocaine	Lidocaine HCl	General Injectables & Vaccines, Inc	NDA	Current
52584-489	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-489	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-489	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-489	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-489	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current
52584-489	Xylocaine	Lidocaine Hydrochloride and epinephrine	General Injectables & Vaccines, Inc	NDA	Current

Documents

Document	Submission type	Date
80054	SUPPL	2024-12-02
80058	SUPPL	2024-11-01
57404	SUPPL	2019-02-01
56307	SUPPL	2018-11-06
56254	SUPPL	2018-11-02
51044	SUPPL	2018-01-12
51043	SUPPL	2018-01-12
50963	SUPPL	2017-12-29
50962	SUPPL	2017-12-29
20009	SUPPL	2012-01-27
80	SUPPL	2010-03-18
10687	SUPPL	2010-02-25