Application 206297

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE	LIDOCAINE	OINTMENT;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
A206297-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2015-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206297-001	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 · 42 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	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A206297-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206297-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206297-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206297-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206297-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206297-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206297-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206297-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206297-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206297-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206297-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206297-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206297-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206297-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206297-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206297-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206297-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206297-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206297-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206297-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206297-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206297-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206297-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206297-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206297-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206297-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206297-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206297-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206297-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206297-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206297-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206297-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206297-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206297-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206297-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206297-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206297-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206297-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206297-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206297-001	AT	1	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	960f6d0a-82af-45e9-89d5-cea808004ebb	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297 ndc (product): 65162-918
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	4806f94d-cbac-4107-b93b-8f715868ffb3	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297 ndc (product): 68788-7376
Lidocaine	LIDOCAINE	PHOENIX RX LLC	40949067-a5a8-db8c-e063-6294a90af0fb	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18b8413-8f52-a927-e053-2a95a90a402a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f93cbde5-329a-f880-e053-6294a90a1af2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	6fe7721d-42b3-4284-936b-a448ca530c45	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	d1509740-f9f1-44e3-8fde-51d8683fcd87	2018-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297 ndc (product): 65162-918

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-379	Lidocaine	Lidocaine	AvKARE, Inc.	ANDA	Current
42291-379	Lidocaine	Lidocaine	AvKARE, Inc.	ANDA	Current
45865-950	Lidocaine	Lidocaine	medsource pharmaceuticals	ANDA	Current
53149-4911	Lidocaine	Lidocaine	All Pharma, LLC	ANDA	Current
53149-4911	Lidocaine	Lidocaine	All Pharma, LLC	ANDA	Current
53149-4913	Lidocaine	Lidocaine	All Pharma, LLC	ANDA	Current
60760-918	Lidocaine	Lidocaine	St. Mary's Medical Park Pharmacy	ANDA	Current
65162-918	Lidocaine	Lidocaine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-918	Lidocaine	Lidocaine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-918	Lidocaine	Lidocaine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-918	Lidocaine	Lidocaine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-918	Lidocaine	Lidocaine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-918	Lidocaine	Lidocaine	Amneal Pharmaceuticals LLC	ANDA	Current
68788-7376	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7376	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7376	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7376	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
69336-103	Lidocaine	Lidocaine	Sterling-Knight Pharmaceuticals, LLC	ANDA	Current
69336-103	Lidocaine	Lidocaine	Sterling-Knight Pharmaceuticals, LLC	ANDA	Current
69336-829	Lidopac	Lidocaine	Sterling-Knight Pharmaceuticals, LLC	ANDA	Current
71205-137	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
71205-137	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10555	ORIG	2015-08-12