Application 084625

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 PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982
A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	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
A084625-001	AP
A084625-002	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 · 88 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
2019-12-13 00:20 UTC	2019-12	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION		Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION		Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION		Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION		Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION		Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION		Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION		Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084625-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084625-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A084625-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A084625-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A084625-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A084625-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084625-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084625-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084625-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084625-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084625-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084625-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084625-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084625-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084625-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084625-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084625-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084625-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084625-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084625-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084625-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084625-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084625-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084625-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084625-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084625-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084625-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084625-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084625-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084625-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084625-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084625-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084625-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084625-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084625-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084625-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084625-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084625-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084625-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084625-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084625-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084625-002	AP	1	`4b0b4de00fa7…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Civica, Inc.	3c3b3888-fad3-440b-b627-6f79a2f4668f	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625 ndc (product): 72572-372 ndc (product): 72572-370
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625 ndc (product): 0143-9595 ndc (product): 0143-9594
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	995e68a7-6986-423e-e053-2995a90acd98	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625 ndc (product): 51662-1438 ndc (product): 51662-1422
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	89691444-7bfb-3314-e053-2a95a90a268e	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625 ndc (product): 71872-7161
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	fecd1797-7757-4da8-b3a1-24b258634243	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084625 application number: ANDA084625 ndc (product): 76420-078

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
0143-9594	Lidocaine Hydrochloride	Lidocaine Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9594	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9595	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9595	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
51662-1422	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1422	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1422	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1422	LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1438	LIDOCAINE HCl	LIDOCAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1438	LIDOCAINE HCl	LIDOCAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1438	LIDOCAINE HCl	LIDOCAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
69263-852	Lidomark 2/5	lidocaine	Oaklock, LLC	ANDA	Current
69263-852	Lidomark 2/5	lidocaine	Oaklock, LLC	ANDA	Current
71872-7161	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
72572-370	Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Civica, Inc.	ANDA	Current
72572-372	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Civica, Inc.	ANDA	Current
76420-078	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
76420-078	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Asclemed USA, Inc.	ANDA	Current