Application 088586

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
003	LIDOCAINE HYDROCHLORIDE	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP		1985-07-24
A088586-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982
A088586-003	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A088586-001	AP
A088586-002	AP
A088586-003	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 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088586-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088586-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088586-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088586-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088586-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088586-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A088586-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A088586-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088586-001	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	INJECTABLE / INJECTION	AP		1985-07-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088586-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088586-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982		`a50c72e98297…`

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	A088586-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A088586-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A088586-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A088586-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088586-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088586-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088586-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088586-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088586-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088586-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088586-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088586-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088586-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088586-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088586-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088586-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088586-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088586-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088586-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088586-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088586-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088586-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088586-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088586-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088586-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088586-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088586-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088586-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088586-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088586-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088586-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088586-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088586-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088586-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088586-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088586-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088586-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088586-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088586-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088586-001	AP	1	`79d66fd596c7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	cffda6fc-7e85-4c48-9623-2551d3552d7d	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088586 application number: ANDA088586
Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	cddb2b22-fce3-8967-6e54-dca3df5ac4b3	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088586 application number: ANDA088586 ndc (product): 63323-201

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current