Application 017508

Type: NDA
Sponsor: ABRAXIS PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	4%	No	No
004	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	20%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N017508-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982
N017508-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982
N017508-004	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017508-002	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017508-004	LIDOCAINE HYDROCHLORIDE	20%	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017508-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`

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 12 of 16 · 304 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine HCl 4 Percent	LIDOCAINE HYDROCHLORIDE	ARI BRANDS, LLC	81aff5c5-91c0-4173-a432-d20115613580	2024-04-30	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Burn	LIDOCAINE HYDROCHLORIDE	JHK Inc	5a4ac4cc-015a-48e7-81f8-93a895049afd	2024-04-25	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine MPF	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	fe265eb5-eaeb-4f47-82dd-238c1d53fec4	2024-03-15	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SunBurnt PLUS	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	12128c75-015d-8a72-e063-6394a90ae00a	2024-02-23	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Kroger Analgesic Analgesic	LIDOCAINE HYDROCHLORIDE	THE KROGER CO	e6c5ead3-87d0-48ed-a4dc-86cf89ebb285	2024-02-22	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0050d05a-b8e9-c544-e063-6294a90a0243	2024-02-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	1c5eb3b3-79b3-472a-ae36-ec6a7dc72925	2024-02-07	Warnings	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	8eb3e7e2-26e5-430e-89aa-40a0367c637e	2024-02-07	Warnings	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c4bf5905-add7-1cb0-e053-2995a90a7334	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c4c0df51-cc37-323d-e053-2995a90a154a	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Seton Pharmaceuticals	1c0abe84-5404-404e-b882-e910e4d43ffb	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	eca272cb-ac8f-982b-e053-2995a90aa8b2	2024-01-15	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Caring mill Lidocaine Aloe Gel Burn and Pain Relief	LIDOCAINE HYDROCHLORIDE	FSA Store Inc.	0ec20c87-1681-dd23-e063-6394a90a291c	2024-01-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE ANHYDROUS	Spectra Medical Devices, LLC	e8ba012a-08a9-4f67-9f88-3284377e80be	2024-01-12	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	09c10cd0-b634-ab9d-e063-6294a90aa544	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Theraworx Pain Relief Roll-On with Lidocaine for Diabetics	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	2024-01-08	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic	LIDOCAINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	bf954949-a7b7-44ba-8565-f1d5c0a6c0d1	2023-12-21	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c5d27da0-e495-4bb6-a7e1-8eaa6595eb71	2023-12-14	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Thera Plus Max Strength Lidocaine Pain Relief Liquid	LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	0a228b06-0e1c-6c75-e063-6294a90a9a0e	2023-11-30	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Southern Sales & Service, Inc.	9089cb78-e9f8-4437-a767-df809a114c4b	2023-11-29	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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