Application 080407

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	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	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
A080407-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982
A080407-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A080407-001	AP
A080407-002	AP

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	Product TE source text	RLD / RS	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080407-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080407-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A080407-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080407-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080407-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080407-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080407-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080407-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080407-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080407-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080407-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080407-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080407-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080407-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080407-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080407-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080407-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080407-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080407-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080407-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080407-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080407-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080407-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080407-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080407-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080407-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080407-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080407-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080407-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080407-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080407-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080407-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080407-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080407-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080407-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080407-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080407-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080407-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080407-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080407-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A080407-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080407-002	AP	1	`bb7c543d1eb4…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	7adb9ab0-ef91-4c51-baa3-a0b7e12df077	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080407 application number: ANDA080407
Lidocaine	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	e6c83ad7-2821-432b-8610-0f54cfe610cb	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080407 application number: ANDA080407 ndc (product): 50090-3366
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	953471e2-9efb-adf0-e053-2a95a90afd95	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080407 application number: ANDA080407 ndc (product): 51662-1384
Lidocaine	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	5523fdfe-69fd-49a5-b51f-73e2223d49a9	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080407 application number: ANDA080407 ndc (product): 0143-9578 ndc (product): 0143-9575 ndc (product): 0143-9577 ndc (product): 0143-9576 ndc (product): 0143-9579
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86083fea-c064-4ef7-e053-2a91aa0ac17c	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080407 application number: ANDA080407 ndc (product): 71872-7156
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86093c75-6dde-bb16-e053-2991aa0ab6ef	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080407 application number: ANDA080407 ndc (product): 71872-7158

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9575	Lidocaine	Lidocaine Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9575	Lidocaine	Lidocaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9576	Lidocaine	Lidocaine Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9576	Lidocaine	Lidocaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9577	Lidocaine	Lidocaine Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9577	Lidocaine	Lidocaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9578	Lidocaine	Lidocaine Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9578	Lidocaine	Lidocaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9579	Lidocaine	LIDOCAINE HYDROCHLORIDE	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9579	Lidocaine	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
50090-3238	Lidocaine	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3238	Lidocaine	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3366	Lidocaine	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
51662-1384	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1384	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1384	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
71872-7156	Lidocaine	Lidocaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7158	Lidocaine	Lidocaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current