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 6 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	335dfa50-56f3-4c02-b713-8eef4e28eb45	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Launch Medical	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	293ef514-44c1-43ac-9a81-c30e34ad39e5	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Tattoo Numbing Cream Co	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	2a64b3ef-ed2d-49db-996d-f63ffecb5a1e	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Painless Tattoo Numbing	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	efd3289f-dfb2-487c-a76f-00fe8af414e3	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Now Numb Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	fed833f5-4f76-46e8-8ae1-655a9e576f70	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Painless Tattoo Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	852504ec-d4fa-4cae-ba89-7ffb57df8efe	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Arte Maximum strength Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	e612a256-3f44-46db-bb6a-e550c2216fdc	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Hello Sugar	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	5f30254d-a28f-443d-8729-5c5dde4a0217	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TattooNumb	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	d9c4d664-54de-40c2-8836-72b60e6d9ac0	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
BeardedMoney	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	35ff688b-75c5-4780-b294-192af780d705	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
NeuroMed 7 Topical Pain Relief	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	f199f56b-d971-4cf8-834d-babb5c2ff81a	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
NeuroMed Topical Anesthetic 7	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals	8a2b6b76-6bcc-4f52-b037-e6cbc74f8377	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
NeuroMed Topical Anesthetic 7	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals	67b25c37-db32-4980-88b0-b07712345939	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidozall	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	1eb2dfb2-3ad1-488b-aed9-17220e34a10c	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidozall Plus	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	ba3cbb15-f4ed-443e-af43-a758481acb0b	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TopCare Pain Relief Maximum Strength	LIDOCAINE HYDROCHLORIDE	TOPCO ASSOCIATES	b0ae3a7c-52d1-4923-bd50-6bb3749006c8	2025-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	5524cbfd-d6e6-42eb-aaa5-22495e0a86b6	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
GuruNanda Pain Relief	LIDOCAINE HYDROCHLORIDE	GuruNanda, LLC.	3ab6a133-8dca-e14e-e063-6394a90a85e7	2025-11-10	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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