Application 080420

Type: ANDA
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	1%	No	No
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No
004	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No
005	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1.5%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A080420-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982
A080420-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982
A080420-004	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982
A080420-005	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1.5%	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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080420-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080420-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080420-004	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080420-005	LIDOCAINE HYDROCHLORIDE	1.5%	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`

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 7 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xylocaine	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	ffc87dfb-0e26-4b42-80fd-3fb7690119e3	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	e67dee40-b243-4d6b-bc6b-e52c6cb798b8	2025-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	f73d4546-c9ac-4155-8492-552d6ce70c84	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	f0617ab8-555f-4cbe-9795-c922f5ef176e	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	ddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	e1badbba-59af-e451-e053-2a95a90a49f8	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC.	42531a38-7cff-de16-e063-6394a90a18d8	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	e6c83ad7-2821-432b-8610-0f54cfe610cb	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Ear Pain MD	LIDOCAINE HYDROCHLORIDE	Eosera Inc	78c4418f-7f0f-447f-a94f-d4c89a081af1	2025-10-17	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Trilocaine	LIDOCAINE HYDROCHLORIDE	Trifluent Pharma LLC	c58257bf-f06b-48d1-92df-a680dbd5eea0	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Trilogel	LIDOCAINE HYDROCHLORIDE	Trifluent Pharma LLC	22af7d63-6a56-4a38-a95b-0f88410b23cb	2025-10-14	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	The J. Molner Company LLC	17880468-873f-6465-e063-6294a90a9c73	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
equate Burn Relief	LIDOCAINE HYDROCHLORIDE	Walmart Inc	a90cbd92-80a5-4463-8152-b83165121a6f	2025-10-02	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Xttrium Laboratories, Inc.	40339593-1142-53ef-e063-6394a90afd4f	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Atlantic Biologicals Corp.	401ecb6c-392b-1d74-e063-6294a90a4005	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE ANHYDROUS	Henry Schein, Inc.	bb53bb10-bb36-4c9b-b632-71455615f9f3	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	ee21518e-b3ed-405a-ac3b-bfe753893dba	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE ANHYDROUS	Henry Schein, Inc.	a5d4b206-cc53-470f-9bca-abfc6ea5cc99	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride
Lidocaine Hydrochloride	LIDOCAINE	Henry Schein, Inc.	0c0790ec-effd-4d8a-9874-8ca0b31e54d0	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride
Medi-First Burn	LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	44bb5f25-1114-4bb1-8bcf-40402594abc4	2025-09-09	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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