Application 206463

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE	LIDOCAINE	PATCH;TOPICAL	5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206463-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL	AB		2020-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206463-001	AB

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.

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	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206463-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206463-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206463-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206463-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206463-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206463-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206463-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206463-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206463-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206463-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206463-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206463-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206463-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206463-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206463-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206463-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206463-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206463-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206463-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206463-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206463-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206463-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206463-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206463-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206463-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206463-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206463-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206463-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206463-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206463-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206463-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206463-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206463-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206463-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206463-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206463-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206463-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206463-001	AB	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	PHOENIX RX LLC	57edfcb8-272c-8af4-e063-6294a90ae2e5	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	ASCLEMED USA INC.	56a54ef4-7aa0-e181-e063-6394a90a3e0e	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	ebc05cf9-e82b-4f7d-b5e7-3e62025ce68c	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine Patch	LIDOCAINE PATCH	Direct_Rx	eb503f1f-cd3a-ab76-e053-2995a90ab1c8	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463 ndc (product): 72189-387
Lidocaine	LIDOCAINE	Sportpharm LLC	1112681c-8de7-472b-8db4-2702054b835b	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	A-S Medication Solutions	82bb7767-5407-4593-b6d4-90859890e376	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	AvKARE	0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f94d388c-8471-885b-e053-6294a90ab67a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	1f46bdfd-3a38-49a3-a505-0192790486d0	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463 ndc (product): 65162-791
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	b4db5684-988f-44c4-a81e-5c04b8b0f6e7	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463 ndc (product): 71335-1971
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	19c585f3-e635-44d4-8eb0-14529eb34dca	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-932	Lidocaine	Lidocaine	Quality Care; Products, LLC	ANDA	Current
55700-932	Lidocaine	Lidocaine	Quality Care; Products, LLC	ANDA	Current
65162-791	Lidocaine	Lidocaine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-791	Lidocaine	Lidocaine	Amneal Pharmaceuticals LLC	ANDA	Current
71335-1971	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
72189-387	Lidocaine Patch	Lidocaine Patch	Direct_Rx	ANDA	Current