Application 214336

Type: ANDA
Sponsor: ASPIRO

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 42.

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
A214336-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP		2021-11-08
A214336-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP		2023-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214336-001	AP
A214336-002	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 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214336-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2023-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214336-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2021-11-08	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214336-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214336-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214336-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214336-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214336-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214336-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214336-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214336-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214336-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214336-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214336-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214336-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214336-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214336-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214336-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214336-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214336-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214336-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214336-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214336-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214336-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214336-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214336-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214336-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214336-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214336-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214336-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214336-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214336-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214336-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214336-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214336-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214336-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214336-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214336-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214336-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214336-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214336-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214336-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214336-001	AP	1	`ea1830bbd6c7…`

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 hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	573a7298-b02e-230c-e063-6294a90a269c	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214336 application number: ANDA214336
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	fa7dedcd-d78b-45f2-9dd7-f273043167d0	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214336 application number: ANDA214336
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	cfbca641-aeee-4dc8-a340-30c53d3b023b	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214336 application number: ANDA214336
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	9a1418e2-b208-4e5c-b5f8-21b3a691a578	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214336 application number: ANDA214336 ndc (product): 31722-116
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	767374af-89d1-4c19-bd8e-480699b45cf7	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214336 application number: ANDA214336
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	NorthStar RxLLC	6a7fa6c5-b550-46ac-99a3-5c49339e6dbd	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214336 application number: ANDA214336

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-116	Lidocaine hydrochloride	Lidocaine hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-116	Lidocaine hydrochloride	Lidocaine hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current