Application 206498

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

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 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
A206498-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2016-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206498-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206498-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-09-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A206498-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206498-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206498-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206498-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206498-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206498-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206498-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206498-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206498-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206498-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206498-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206498-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206498-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206498-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206498-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206498-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206498-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206498-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206498-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206498-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206498-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206498-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206498-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206498-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206498-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206498-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206498-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206498-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206498-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206498-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206498-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206498-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206498-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206498-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206498-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206498-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206498-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206498-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206498-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206498-001	AT	1	`cb3db0bc1861…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lidocaine	LIDOCAINE	REMEDYREPACK INC.	2cc3d25d-cefd-448d-beec-ac602c2110fd	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	REMEDYREPACK INC.	499b4443-7aed-4ac5-ab16-f47e759c3201	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Northstar Rx LLC	cde68b0c-a1ee-421d-9ca8-bc571d2990ab	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498 ndc (product): 16714-878
lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	54df7353-5411-43ad-bd7b-a3d4d62c72c6	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
Lidocaine	LIDOCAINE	Direct_Rx	00725e5b-694c-b9e1-e063-6294a90a4182	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	A-S Medication Solutions	967b0c5d-679d-4b69-9d6a-bc322baf6e04	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	PHOENIX RX LLC	3a602aee-09e2-892c-e063-6294a90a558f	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	4134f30d-5cb0-e14b-e063-6394a90a4523	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18bae4a-11ac-7319-e053-2995a90ad1e8	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	259f7b21-98c7-3b41-e063-6294a90a34fa	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Asclemed USA, Inc.	58c9afe4-dc36-4f71-8e76-8dff63dc35fb	2023-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498
lidocaine	LIDOCAINE	Proficient Rx LP	8a85ea77-91ad-4222-9bfe-2ffaf73182e8	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498 ndc (product): 71205-717
lidocaine	LIDOCAINE	Proficient Rx LP	f9b290d2-0e24-4ca8-bca2-3016f5c404df	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498 ndc (product): 71205-500
lidocaine	LIDOCAINE	Glenmark Pharmaceuticals Inc., USA	eaa15be7-11ea-49bc-ac07-739075453be6	2021-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498 ndc (product): 68462-418
lidocaine	LIDOCAINE	Asclemed USA, Inc.	6abf3773-0e60-48b1-9d5c-adc590363d13	2021-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206498 application number: ANDA206498 ndc (product): 76420-125

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-878	lidocaine	lidocaine	Northstar Rx LLC	ANDA	Current
45865-990	lidocaine	lidocaine	medsource pharmaceuticals	ANDA	Current
53149-4910	lidocaine	lidocaine	All Pharma, LLC	ANDA	Current
53149-4910	lidocaine	lidocaine	All Pharma, LLC	ANDA	Current
53149-4912	lidocaine	lidocaine	All Pharma, LLC	ANDA	Current
53149-4912	lidocaine	lidocaine	All Pharma, LLC	ANDA	Current
68462-418	lidocaine	lidocaine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-418	lidocaine	lidocaine	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68788-6319	lidocaine	lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6319	lidocaine	lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6319	lidocaine	lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-500	lidocaine	lidocaine	Proficient Rx LP	ANDA	Current
71205-500	lidocaine	lidocaine	Proficient Rx LP	ANDA	Current
71205-500	lidocaine	lidocaine	Proficient Rx LP	ANDA	Current
71205-717	lidocaine	lidocaine	Proficient Rx LP	ANDA	Current
76420-125	lidocaine	lidocaine	Asclemed USA, Inc.	ANDA	Current
80175-0418	LIDOCAINE	LIDOCAINE	Central Packaging	ANDA	Current
80175-0418	LIDOCAINE	LIDOCAINE	Central Packaging	ANDA	Current
80175-0418	LIDOCAINE	LIDOCAINE	Central Packaging	ANDA	Current