Application 040708

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	SOLUTION;ORAL	2%	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		2007-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040708-001	AT

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	RS	2007-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL			2007-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL			2007-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	RS	2007-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	RS	2007-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	RS	2007-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040708-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040708-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040708-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040708-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040708-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040708-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040708-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040708-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040708-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040708-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040708-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040708-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040708-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040708-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040708-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040708-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040708-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040708-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040708-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040708-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040708-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040708-001	AT	1	`5aa47cf7b7d7…`
2019-12-14 00:12 UTC	2019-12	A040708-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040708-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040708-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040708-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040708-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040708-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040708-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040708-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040708-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040708-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040708-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040708-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040708-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040708-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040708-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040708-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040708-001	AT	1	`a50c72e98297…`

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	Chartwell RX, LLC	c05f49a2-7512-48e7-9730-f8ee05519b9d	2026-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040708 application number: ANDA040708
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	f79b8b30-67ed-4daa-8233-ee2319592ef0	2026-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040708 application number: ANDA040708
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Lannett Company, Inc.	c3353e08-2a8c-4ace-ba89-114f7131b8de	2025-08-07	Warnings, Adverse reactions	Exact identifier ndc (product): 0527-6004

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6004	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-6004	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Lannett Company, Inc.	ANDA	Current
16714-097	Lidocaine Hydrochloride	Lidocaine Hydrochloride	NorthStar RxLLC	ANDA	Current
16714-097	Lidocaine Hydrochloride	Lidocaine Hydrochloride	NorthStar RxLLC	ANDA	Current
17856-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-6002	Lidocaine Hydrochloride	Lidocaine Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50090-5599	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5667	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5667	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-1827	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Unit Dose Services	ANDA	Current
53002-3431	Lidocaine Hydrochloride	Lidocaine Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
61919-247	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-247	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	DIRECT RX	ANDA	Current
63629-2095	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2095	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63739-694	Lidocaine Hydrochloride	Lidocaine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-694	Lidocaine Hydrochloride	Lidocaine Hydrochloride	McKesson Corporation	ANDA	Current
76420-190	Lidocaine Hydrochloride	Lidocaine Hydrochloride	Asclemed USA, Inc.	ANDA	Current
81646-143	Lidocaine Hydrochloride	Lidocaine Hydrochloride	PINNACLE PHARMA LLC	ANDA	Current