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 5 of 16 · 304 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0.5% LIDOCAINE BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	0a1aeff0-bade-457b-a0ac-099d646c0b2e	2026-01-08	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
2.0% LIDOCAINE BURN	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	e1911279-85f7-4053-b6da-8f4e991347a2	2026-01-08	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Precision Dose, Inc.	27b6ef54-a093-2bef-e063-6394a90a7912	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
WALGREENS BURN	LIDOCAINE HYDROCHLORIDE	WALGREENS	b61e6d73-4f41-ef50-e053-2a95a90a0fc6	2025-12-29	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme with Lidocaine Foot Pain Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	da82cc0e-cc39-408e-87e1-c35bb6f9f51e	2025-12-19	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	38560997-cfe4-2f9b-e063-6394a90a834b	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	3f2c33e5-290e-2f89-e063-6394a90aee69	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	42caf92e-6fa9-5bd7-e063-6294a90a3904	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	42d9e4cf-ca73-ec6d-e063-6394a90ae937	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	3f2bdb1f-f1c0-370d-e063-6294a90a5c50	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	4643042c-ec95-3bad-e063-6294a90a8250	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cardinal Health 107, LLC	4e46cac7-00cd-4a01-ba11-9af4960cfbe9	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Gold Bond Medicated Pain and Itch Relief	LIDOCAINE HYDROCHLORIDE	Gold Bond Co LLC	d240e9b8-3506-42ab-8a50-05e8d3fac4ff	2025-12-04	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
POMG NIGHT TIME PAIN RELIEF ROLLER	LIDOCAINE HYDROCHLORIDE	POMG LLC	28d7dfb0-a94c-90de-e063-6294a90a036a	2025-12-02	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Brookfield Pharmaceuticals, LLC.	e824ba5b-3289-5ad4-e053-2995a90acc20	2025-11-27	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Walgreen Pain Relieving Fragrance Free	LIDOCAINE HYDROCHLORIDE	WALGREENS CO.	62c50ded-3fc9-4f65-9bfb-1144ed2e36b4	2025-11-26	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	82b377ee-0e3e-4cb9-a644-f45434c21cca	2025-11-26	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	42df73b0-20ee-d1aa-e063-6294a90aa275	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Dextrum Laboratories, Inc	441daa6f-f273-ac09-e063-6394a90a252c	2025-11-21	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	313a7e1f-c1a9-4fa5-bb83-7256c271b351	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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