Application 207182

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 1.

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
A207182-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP		2017-10-30
A207182-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP		2017-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207182-001	AP
A207182-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207182-001	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	2017-10-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207182-002	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	2017-10-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207182-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207182-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207182-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207182-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207182-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207182-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207182-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207182-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207182-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207182-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207182-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207182-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207182-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207182-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207182-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207182-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207182-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207182-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207182-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207182-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207182-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207182-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207182-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207182-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207182-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207182-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207182-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207182-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207182-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207182-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207182-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207182-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207182-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207182-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207182-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207182-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207182-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207182-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207182-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207182-002	AP	1	`782e0a99824c…`

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	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	415a29c1-101a-4ac2-9ba9-b419a1ce5600	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207182 application number: ANDA207182
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cardinal Health 107, LLC	32513e8b-2a81-436e-8da2-439c1dcbf116	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207182 application number: ANDA207182 ndc (product): 55154-8337
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	ccc38d8a-43fd-44c0-985e-32af9ed956ab	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207182 application number: ANDA207182 ndc (product): 55150-255 ndc (product): 55150-252 ndc (product): 55150-251 ndc (product): 55150-254
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	ef782e5e-e2d7-465a-99c6-b12611f3158c	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207182 application number: ANDA207182 ndc (product): 55150-255 ndc (product): 55150-252 ndc (product): 55150-256 ndc (product): 55150-251 ndc (product): 55150-253 ndc (product): 55150-254
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	45416533-17a1-4757-b24e-b33d1ee57471	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207182 application number: ANDA207182
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	0a353fe1-b779-3d1f-e063-6294a90ab21b	2023-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207182 application number: ANDA207182
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	b63614eb-8776-4cd0-e053-2995a90a8f82	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207182 application number: ANDA207182 ndc (product): 71872-7233
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	c8e7f9ef-1982-b8ce-e053-2a95a90ac4ee	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207182 application number: ANDA207182 ndc (product): 71872-7254
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	c8e8b217-a183-0d91-e053-2a95a90a4a44	2023-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207182 application number: ANDA207182 ndc (product): 71872-7256

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55150-251	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-251	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-251	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-251	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-252	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-252	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-252	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-252	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-253	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-253	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-253	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-253	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-254	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-254	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-254	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-254	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-255	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-255	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-255	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-255	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-256	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-256	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-256	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-256	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55154-8337	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health	ANDA	Current
55154-8337	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health	ANDA	Current
55154-8337	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
70518-2011	Lidocaine Hydrochloride	Lidocaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2011	Lidocaine Hydrochloride	Lidocaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2011	Lidocaine Hydrochloride	Lidocaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2011	Lidocaine Hydrochloride	Lidocaine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71872-7233	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7254	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7256	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current