Application 086724

Type: ANDA
Sponsor: TARO

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 44.

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
A086724-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086724-001	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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A086724-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A086724-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A086724-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086724-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086724-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086724-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086724-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086724-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086724-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086724-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086724-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086724-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086724-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086724-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086724-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086724-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086724-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086724-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086724-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086724-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086724-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086724-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086724-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086724-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086724-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086724-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086724-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086724-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086724-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086724-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086724-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086724-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086724-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086724-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086724-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086724-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086724-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086724-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086724-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086724-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086724-001	AT	1	`3a93d1ddd44b…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	A-S Medication Solutions	2bb5b298-3802-446c-b8cd-313e84bff04e	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Sun Pharmaceutical Industries, Inc.	5eb2c62f-5352-41d7-bd66-c65b1988a9ab	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724 ndc (product): 51672-3008
LIDOCAINE	LIDOCAINE	DIRECT RX	b8663046-67a4-4858-e053-2a95a90a8aed	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724 ndc (product): 72189-165 ndc (product): 72189-211
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	851844f5-912d-4598-84f3-c0277968b5f1	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	PHOENIX RX LLC	3ff29d56-8f20-6376-e063-6294a90a667b	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	3a9a6630-e470-b794-e063-6394a90aaab5	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Golden State Medical Supply, Inc.	b948d6fe-3893-39a1-e053-2995a90ae64c	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724 ndc (product): 51407-383
Lidocaine	LIDOCAINE	Sun Pharmaceutical Industries, Inc.	ae758020-a508-4a2e-8164-e6c324e826a3	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724 ndc (product): 51672-3020
Lidocaine	LIDOCAINE	ATLANTIC BIOLOGICALS CORP.	1e8239f6-8d53-4b04-8bf8-c2cefe3ab5c3	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724 ndc (product): 17856-3008
Lidocaine	LIDOCAINE	NuCare Pharmaceuticals, Inc.	2e0f4ca3-874a-f0d0-e063-6294a90a0b65	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Quality Care Products, LLC	7bb5c092-91da-4789-b348-58548703d716	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724
Lidocaine	LIDOCAINE	Proficient Rx LP	f1007717-528a-42e2-94aa-db0edf3bb603	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086724 application number: ANDA086724 ndc (product): 71205-288

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-3008	Lidocaine	Lidocaine	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-3008	Lidocaine	Lidocaine	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
42291-378	Lidocaine	Lidocaine	AvKARE, Inc.	ANDA	Current
45865-922	Lidocaine	Lidocaine	medsource pharmaceuticals	ANDA	Current
51407-383	Lidocaine	Lidocaine	Golden State Medical Supply, Inc.	ANDA	Current
51407-383	Lidocaine	Lidocaine	Golden State Medical Supply, Inc.	ANDA	Current
51407-383	Lidocaine	Lidocaine	Golden State Medical Supply, Inc.	ANDA	Current
51672-3008	Lidocaine	Lidocaine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-3008	Lidocaine	Lidocaine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-3008	Lidocaine	Lidocaine	Taro Pharmaceuticals U.S.	ANDA	Current
51672-3020	Lidocaine	Lidocaine	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55700-336	Lidocaine	Lidocaine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-836	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
63187-836	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
63187-934	Lidocaine	LIDOCAINE	Proficient Rx LP	ANDA	Current
63187-934	Lidocaine	LIDOCAINE	Proficient Rx LP	ANDA	Current
63187-934	Lidocaine	LIDOCAINE	Proficient Rx LP	ANDA	Current
63187-975	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
63187-975	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
68071-2322	Lidocaine	Lidocaine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6335	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6428	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7555	Lidocaine	Lidocaine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7865	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7865	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3056	Lidocaine	Lidocaine	REMEDYREPACK INC.	ANDA	Current
70518-3056	Lidocaine	Lidocaine	REMEDYREPACK INC.	ANDA	Current
71085-001	Lidocaine	LIDOCAINE	IPG Pharmaceuticals, Inc.	ANDA	Current
71085-011	Lidocaine	Lidocaine	IPG PHARMACEUTICALS, INC.	ANDA	Current
71205-288	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
71205-288	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
71205-288	Lidocaine	Lidocaine	Proficient Rx LP	ANDA	Current
72189-165	LIDOCAINE	LIDOCAINE	LIDOCAINE	ANDA	Current
72189-165	LIDOCAINE	LIDOCAINE	LIDOCAINE	ANDA	Current
72189-165	LIDOCAINE	LIDOCAINE	LIDOCAINE	ANDA	Current
72189-165	LIDOCAINE	LIDOCAINE	DIRECT RX	ANDA	Current
72189-165	LIDOCAINE	LIDOCAINE	DIRECT RX	ANDA	Current
72189-211	LIDOCAINE	LIDOCAINE	LIDOCAINE	ANDA	Current
72189-211	LIDOCAINE	LIDOCAINE	DIRECT RX	ANDA	Current
72189-211	LIDOCAINE	LIDOCAINE	DIRECT RX	ANDA	Current