Application 006488

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N006488-002	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-003	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982
N006488-004	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-005	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N006488-007	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-008	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-010	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-012	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-017	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N006488-018	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13
N006488-019	XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N006488-002	AP
N006488-004	AP
N006488-007	AP
N006488-008	AP
N006488-010	AP
N006488-012	AP
N006488-017	AP
N006488-019	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 12 · 473 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-012	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-017	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-018	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;1%	INJECTABLE / INJECTION		RLD, RS	1986-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-019	XYLOCAINE W/ EPINEPHRINE	0.005MG/ML;2%	INJECTABLE / INJECTION	AP	RLD, RS	1986-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-002	XYLOCAINE	2%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-003	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-004	XYLOCAINE W/ EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-005	XYLOCAINE W/ EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-007	XYLOCAINE	1%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-008	XYLOCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-010	XYLOCAINE	1.5%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 363 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N006488-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-007	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-008	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-010	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-012	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-017	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N006488-019	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N006488-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-010	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-012	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-017	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N006488-019	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N006488-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-010	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-012	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-017	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006488-019	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-010	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-012	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-017	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006488-019	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006488-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-010	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-012	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-017	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006488-019	AP	1	`6a471c1ec25d…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xylocaine MPF	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
LIDOCAINE HCI AND EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	a0997348-6274-060a-e053-2a95a90abea7	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488 ndc (product): 51662-1505
LIDOCAINE HCI AND EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	a09af094-7cfc-1d47-e053-2a95a90a6b69	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488 ndc (product): 51662-1506
XYLOCAINE	XYLOCAINE	HF Acquisition Co LLC, DBA HealthFirst	e3b3b462-8f35-68b8-e053-2995a90a6403	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488 ndc (product): 51662-1590 ndc (product): 51662-1591
XYLOCAINE- MPF (LIDOCAINE HCl )	LIDOCAINE HCL	HF Acquisition Co LLC, DBA HealthFirst	e8b987c8-b5cb-74cd-e053-2a95a90a5a93	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488 ndc (product): 51662-1604
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)	HF Acquisition Co LLC, DBA HealthFirst	971439ed-4507-7a30-e053-2a95a90a1f1c	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488 ndc (product): 51662-1405
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	94e9f2db-af29-032e-e053-2995a90a7f7b	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488 ndc (product): 51662-1412
XYLOCAINE	XYLOCAINE	HF Acquisition Co LLC, DBA HealthFirst	0c6c5678-e987-b822-e063-6394a90ac88b	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	A-S Medication Solutions	38610ee9-4e70-4a8a-a5c5-6c148cf145f0	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	ba082c2f-64f4-419d-9c88-74f203316e17	2021-08-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006488 application number: NDA006488

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 205 matching rows.

NDC, Name, Nonproprietary name table
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 table
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