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 13 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	0a353fe1-b779-3d1f-e063-6294a90ab21b	2023-11-15	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
MAXOCAINE Lidocaine Hemp Oil Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Prime Commerce, LLC	28ed2149-38d2-4062-8442-990a98a69cfc	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SUGAR BRANDS Rescue Pain Relief and Recovery	LIDOCAINE HYDROCHLORIDE	Sugar Brands, LLC	74013709-d1d5-4425-825d-eee726718c61	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
NATURES CRAFT LIDOCAINE Male Genital Desensitizer	LIDOCAINE HYDROCHLORIDE	Natures Design Products LLC	61bf1776-5c6c-4307-8348-41fa60164017	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
KARMA RUB Elemental Pain Relief	LIDOCAINE HYDROCHLORIDE	Elemental Bliss LLC	c224fb1b-827f-461e-a58f-4020700c3e0d	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
INTIMALE Maximum Strength Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25b9ade3-72b0-4b86-8c48-90310a26806f	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
POWERECT Max Power Male Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25a1c926-9543-44a7-865e-a4b6e1a40cbe	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SKINS DELAY Maximum Strength Lidocaine	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	172efe5d-28b8-443c-b3f9-429669189081	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOSOLVE PAIN RELIEF	LIDOCAINE HYDROCHLORIDE	HENNIKA HEALTH, LLC	3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	65a319a6-89d2-44c9-81d5-30327f9948cb	2023-11-10	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	768f3f0e-1add-404f-b869-00a9f35ad34a	2023-11-10	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Uber Numb Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	UberScientific, LLC	441c802f-a363-1530-e054-00144ff88e88	2023-11-10	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Uber Numb Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	UberScientific, LLC	4939a547-c94b-3350-e054-00144ff88e88	2023-11-10	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
DOCTORS TOUCH Erase The Pain Lidocaine	LIDOCAINE HYDROCHLORIDE	DOCTOR'S CHOICE MEDICAL, LLC	3dc9947b-8196-4a38-97b4-c2340ee77e0f	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
RadiaGuard Advanced Radiation Relief	LIDOCAINE HYDROCHLORIDE	SMOOTH SIDE, INC	21205087-5a2e-41a5-be40-30cba2895408	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SKINS DELAY Climax Control Lidocaine	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	0db91010-12f7-4f20-b96c-432915720d5a	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
POWERECT Lidocaine Male Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	42e0c40f-1efd-45ef-815d-53d193d720eb	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
WAXUP Numbing	LIDOCAINE HYDROCHLORIDE	CONSTRUSOLUTION, LLC	4f1645ab-1b19-4d69-99c3-9ea275b01a87	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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