Application 203040

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION			2013-03-14
A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION			2013-03-14

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	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION		2013-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION		2013-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION		2013-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION		2013-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION		2013-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION		2013-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203040-001	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%	INJECTABLE / INJECTION	AP	2013-03-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203040-002	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%	INJECTABLE / INJECTION	AP	2013-03-14	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203040-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203040-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203040-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203040-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203040-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203040-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203040-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203040-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203040-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203040-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203040-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203040-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203040-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203040-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203040-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203040-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203040-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203040-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203040-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203040-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203040-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203040-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203040-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203040-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203040-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203040-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203040-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203040-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203040-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203040-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203040-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203040-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203040-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203040-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203040-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203040-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203040-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203040-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203040-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203040-002	AP	1	`8869cabd3fbd…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	5524cbfd-d6e6-42eb-aaa5-22495e0a86b6	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203040 application number: ANDA203040 ndc (product): 55150-159 ndc (product): 55150-158 ndc (product): 55150-160
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e412b4c-e24f-69ea-e053-2995a90ac600	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203040 application number: ANDA203040 ndc (product): 71872-7190
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	8ae0656c-36fb-48fb-886b-1031d11da552	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203040 application number: ANDA203040 ndc (product): 76420-079

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55150-158	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-158	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-158	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-158	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-159	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-159	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-159	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-159	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-160	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-160	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-160	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
55150-160	Lidocaine Hydrochloride	Lidocaine Hydrochloride	AuroMedics Pharma LLC	ANDA	Current
69263-851	Lidomark 1/5	lidocaine	Oaklock, LLC	ANDA	Current
69263-851	Lidomark 1/5	lidocaine	Oaklock, LLC	ANDA	Current
70859-039	Point Of Care LM 2.2	Lidocaine Hydrochloride,Bupivaine HCI,Isopropyl ,Povidone-lodine	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-039	Point Of Care LM 2.2	Lidocaine Hydrochloride,Bupivaine HCI,Isopropyl ,Povidone-lodine	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-040	Point Of Care LM 2.5	Lidocaine HCI,Bupivacaine HCI,Isopropyl Alcohol,Povidone-Iodine	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-040	Point Of Care LM 2.5	Lidocaine HCI,Bupivacaine HCI,Isopropyl Alcohol,Povidone-Iodine	NuCare Pharmaceuticals,Inc.	ANDA	Current
71872-7190	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
76420-079	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
76420-079	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Asclemed USA, Inc.	ANDA	Current