Application 080406

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.01MG/ML;1%	No	No
002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.01MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;1%	INJECTABLE / INJECTION		RLD, Approved before 1982
A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2%	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 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080406-001	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;1%	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080406-002	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	0.01MG/ML;2%	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`

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 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	2f94f711-14c4-48ec-c5a3-c5ec4b8e8729	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	27194739-3382-46b0-94cd-096531345325	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Cardinal Health 107, LLC	77fd6ee4-108f-4525-8df5-7db9236042ee	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	5569d607-f1cb-4f1d-8a00-d50433ec05d3	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Sportpharm LLC	2c58deba-dbb2-4e73-a173-36053536f03e	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	c3490a23-14c4-43f7-b066-96a4c4298fde	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	ProPharma Distribution	43048b6b-3c83-eef4-e063-6294a90a34cb	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	e0e621d2-10b0-4cdf-b31d-c19b1e86ba6b	2025-06-03	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and Epinephrine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein, Inc.	5692e28d-559c-4b6a-8421-fa85d7155818	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride and Epinephrine

Reported adverse events (FAERS/openFDA)#

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