Application 207810

Type: ANDA
Sponsor: ALKEM LABS 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
A207810-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2017-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207810-001	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	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207810-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-03-10	`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	A207810-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207810-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207810-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207810-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207810-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207810-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207810-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207810-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207810-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207810-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207810-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207810-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207810-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207810-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207810-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207810-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207810-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207810-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207810-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207810-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207810-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207810-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207810-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207810-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207810-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207810-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207810-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207810-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207810-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207810-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207810-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207810-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207810-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207810-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207810-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207810-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207810-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207810-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207810-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207810-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOCAINE	LIDOCAINE	DIRECT RX	b8663046-67a4-4858-e053-2a95a90a8aed	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810 ndc (product): 72189-168
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	a134c265-4fb6-4c78-b9cc-fae8f1fff1cf	2023-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810 ndc (product): 63629-8848
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	68bc320f-2871-45b9-815e-bb26081e8249	2023-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810 ndc (product): 63629-2503
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	da9707e2-f830-45e2-a300-1f99cf3dd362	2023-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810 ndc (product): 63629-2504
Lidocaine	LIDOCAINE	Proficient Rx LP	2c396307-cf12-41d0-89e6-0f4ec74df55e	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207810 application number: ANDA207810 ndc (product): 71205-549

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-9715	Lidocaine	Lidocaine	Liberty Pharmaceuticals, Inc.	ANDA	Current
50436-0473	Lidocaine	Lidocaine	Unit Dose Services	ANDA	Current
50436-0473	Lidocaine	Lidocaine	Unit Dose Services	ANDA	Current
52959-993	LIDOCAINE	LIDOCAINE	H.J. Harkins Company, Inc.	ANDA	Current
55700-681	Lidocaine	Lidocaine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-681	Lidocaine	Lidocaine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-681	Lidocaine	Lidocaine	Lake Erie Medical DBA Qua	ANDA	Current
55700-681	Lidocaine	Lidocaine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-473	Lidocaine	Lidocaine	St. Mary's Medical Park Pharmacy	ANDA	Current
63629-2503	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-2503	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-2504	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-2504	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-8848	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-8848	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-8848	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
67877-473	Lidocaine	Lidocaine	Ascend Laboratories, LLC	ANDA	Current
67877-473	Lidocaine	Lidocaine	Ascend Laboratories, LLC	ANDA	Current
67877-473	Lidocaine	Lidocaine	Ascend Laboratories, LLC	ANDA	Current
70518-2147	Lidocaine	Lidocaine	REMEDYREPACK INC.	ANDA	Current
70518-2147	Lidocaine	Lidocaine	REMEDYREPACK INC.	ANDA	Current
70518-2147	Lidocaine	Lidocaine	REMEDYREPACK INC.	ANDA	Current
70518-2147	Lidocaine	Lidocaine	REMEDYREPACK INC.	ANDA	Current
71205-549	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
71205-549	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
71205-549	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
71205-549	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
71205-549	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
72189-168	LIDOCAINE	LIDOCAINE	LIDOCAINE	ANDA	Current
72189-168	LIDOCAINE	LIDOCAINE	LIDOCAINE	ANDA	Current
72189-168	LIDOCAINE	LIDOCAINE	DIRECT RX	ANDA	Current
72189-168	LIDOCAINE	LIDOCAINE	DIRECT RX	ANDA	Current