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 15 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	c8e7f9ef-1982-b8ce-e053-2a95a90ac4ee	2023-04-27	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	c8e8b217-a183-0d91-e053-2a95a90a4a44	2023-04-25	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	55a8372e-70d6-4b70-ac95-5226d0f5812a	2023-03-02	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
PharmapureRx Lidocaine HCl 4.12%	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	b7a77ad1-821b-4388-a97c-aadb1340c536	2023-01-11	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	5d3e9984-cef9-46f2-a6c9-3be8b26f45b3	2022-12-29	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Bactine Max Dry	LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	466404cd-c46a-4944-b1ac-3b3b17f436a1	2022-12-27	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	B. Braun Medical Inc.	e0e479e6-4c94-44d0-8074-d0ee7b2bde22	2022-10-13	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	fecd1797-7757-4da8-b3a1-24b258634243	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	8ae0656c-36fb-48fb-886b-1031d11da552	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	deec52c7-ebcf-422e-beab-bc1df2fe30cb	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidotran	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	cf715e54-c413-1e8f-e053-2995a90a076d	2022-09-19	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Novitium Pharma LLC	ffb2d794-2c88-48a2-beff-d01b6fcea51f	2022-03-25	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lydexa 4.12%	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	aa1c9d39-1283-8c6b-e053-2a95a90af5b5	2022-03-02	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	2c48cfac-81eb-4a81-8590-bc94574dd4c3	2021-12-14	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	ba082c2f-64f4-419d-9c88-74f203316e17	2021-08-25	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	6702589d-6a15-40fe-877a-a9a1a4ad0f7a	2020-11-30	Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Proficient Rx LP	5b4b36dd-da60-47de-a2c1-517a52ab3549	2020-05-01	Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	b8803e38-fe30-48ec-9399-013f2880e0eb	2020-04-09	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
DermacinRx Lidotral	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	23efec58-67cc-418d-85f5-7ef156443cbf	2019-02-04	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Eha	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	09835640-55c3-4bfa-9ad3-15d37f06e871	2018-11-01	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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