Application 080504

Type: ANDA
Sponsor: BELMORA LLC

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
004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.01MG/ML;2%	No	No
005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.02MG/ML;2%	No	No

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

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	Approval date
A080504-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982
A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19
A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080504-004	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080504-005	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.02MG/ML;2%	INJECTABLE / INJECTION		1983-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080504-001	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	Approved before 1982		`301d65b070ca…`

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 16 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SunBurnt PLUS Pain Relief	LIDOCAINE HYDROCHLORIDE	Welmedix LLC dba Welmedix Consumer Healthcare	6363c695-f801-407d-a4e1-b0d9cfa0a273	2018-03-13	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
FSK-5	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	4c62196a-9f94-4823-b95f-447f012f10bf	2017-12-07	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
EBSS-5	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	7e21b96a-3d89-4d1c-9ec6-0611f6c9c625	2017-12-07	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
IWK-5	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	f291841e-ccbd-4f5a-b1de-4cf596a167e3	2017-12-07	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
EBSL-5	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	0d2631c1-93fc-478c-afed-0f175a7e8555	2017-12-07	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Unburn	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	0c504ba8-8a40-43dd-8c68-62ed106b32a2	2017-12-01	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Unburn	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	40164231-1556-4714-9e27-9d41e3c71447	2017-11-30	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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