Application 200675

Type: ANDA
Sponsor: ACTAVIS LABS UT INC

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 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
A200675-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL	AB		2012-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200675-001	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.

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	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`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	A200675-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200675-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200675-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200675-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200675-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200675-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200675-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200675-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200675-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200675-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200675-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200675-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200675-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200675-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200675-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200675-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200675-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200675-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200675-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200675-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200675-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200675-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200675-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200675-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200675-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200675-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200675-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200675-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200675-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200675-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200675-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200675-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200675-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200675-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200675-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200675-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200675-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200675-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200675-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200675-001	AB	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tridacaine II	LIDOCAINE	Trifluent Pharma LLC	1e940ba6-3916-4fc4-8886-481fc9685fc1	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	PureTek Corporation	85e72943-6989-42f4-b519-a3ebbf4bc777	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 59088-396
Lidocaine	LIDOCAINE	Cardinal Health 107, LLC	eb808fdf-0420-45e9-ad17-8380d49d5c21	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 55154-2665
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	c18799cd-9e11-4196-9ab1-0a2a84585e56	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 0591-2679
LMR Plus	LIDOCAINE	V2 Pharma, LLC	7c84e443-67fe-40b5-b721-86e9e7c4d490	2024-12-30	Warnings, Adverse reactions	Exact identifier ndc (product): 72835-501
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	4e856dd5-f2fa-4acb-a205-f87baf26b8cc	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 63629-7059
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	1d28d687-695e-4cd9-97e2-7d4fdab9772a	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 63629-8755
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	6d7fdc43-e493-449e-9af6-825e584b547a	2023-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 63629-5094
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	80dadfb5-cbe6-475f-9980-a1b255982753	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 76420-037
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	4d04052c-3e0a-469a-9265-99604f13e507	2022-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 0591-3525
Lidocaine	LIDOCAINE	AVKARE	ec6a4720-9821-c0fc-e053-2995a90a05df	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 42291-495
Lidoxryl	LIDOCAINE	PureTek Corporation	1c33790b-8d57-46e8-bd6e-5a0f87a3c29f	2020-11-10	Warnings, Adverse reactions	Exact identifier ndc (product): 59088-722
LidoPure Patch	LIDOCAINE	PureTek Corporation	c851c6e9-1966-4639-9406-fe6adc91c9d0	2020-11-10	Warnings, Adverse reactions	Exact identifier ndc (product): 59088-712

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2679	Lidocaine	Lidocaine	Actavis Pharma, Inc.	ANDA	Current
0591-2679	Lidocaine	Lidocaine	Actavis Pharma, Inc.	ANDA	Current
0591-3525	Lidocaine	Lidocaine	Actavis Pharma, Inc.	ANDA	Current
0591-3525	Lidocaine	Lidocaine	Actavis Pharma, Inc.	ANDA	Current
16714-177	Lidocaine	Lidocaine	Northstar RxLLC	ANDA	Current
16714-177	Lidocaine	Lidocaine	Northstar RxLLC	ANDA	Current
16714-177	Lidocaine	Lidocaine	Northstar RxLLC	ANDA	Current
42291-495	Lidocaine	Lidocaine	AvKARE	ANDA	Current
45865-912	Lidocaine	Lidocaine	medsource pharmaceuticals	ANDA	Current
50090-1358	Lidocaine	Lidocaine	A-S Medication Solutions	ANDA	Current
50436-1330	Lidocaine	Lidocaine	Unit Dose Services	ANDA	Current
50436-3525	Lidocaine	Lidocaine	Unit Dose Services	ANDA	Current
55154-2665	Lidocaine	Lidocaine	Cardinal Health 107, LLC	ANDA	Current
55154-2665	Lidocaine	Lidocaine	Cardinal Health	ANDA	Current
55154-2665	Lidocaine	Lidocaine	Cardinal Health	ANDA	Current
55700-025	Lidocaine	Lidocaine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
59088-396	Lidocaine	Lidocaine	PureTek Corporation	ANDA	Current
59088-396	Lidocaine	Lidocaine	PureTek Corporation	ANDA	Current
59088-396	Lidocaine	Lidocaine	PureTek Corporation	ANDA	Current
59088-712	LidoPure Patch	Lidocaine	PureTek Corporation	ANDA	Current
59088-712	LidoPure Patch	Lidocaine	PureTek Corporation	ANDA	Current
59088-714	Zilacaine Patch	Lidocaine	PureTek Corporation	ANDA	Current
59088-714	Zilacaine Patch	Lidocaine	PureTek Corporation	ANDA	Current
59088-722	Lidoxryl	Lidocaine	PureTek Corporation	ANDA	Current
59088-722	Lidoxryl	Lidocaine	PureTek Corporation	ANDA	Current
60760-201	Lidocaine	Lidocaine	St. Mary's Medical Park Pharmacy	ANDA	Current
63629-5094	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-5094	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-5094	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-7059	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-8755	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-8755	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-8755	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
63629-8755	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
68071-1723	Lidocaine	Lidocaine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2684	Lidocaine	Lidocaine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7617	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7617	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7617	Lidocaine	Lidocaine	Preferred Pharmaceuticals Inc.	ANDA	Current
69621-807	Neurcaine	lidocaine	Shoreline Pharmaceuticals	ANDA	Current
70518-0926	Lidocaine	Lidocaine	REMEDYREPACK INC.	ANDA	Current
70518-0926	Lidocaine	Lidocaine	REMEDYREPACK INC.	ANDA	Current
70518-0926	Lidocaine	Lidocaine	REMEDYREPACK INC.	ANDA	Current
71335-0994	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
71335-0994	Lidocaine	Lidocaine	Bryant Ranch Prepack	ANDA	Current
72275-705	Zenevix	Lidocaine Patch, Sublingual Tincture	Primary Pharmaceuticals, Inc.	ANDA	Current
72275-705	Zenevix	Lidocaine Patch, Sublingual Tincture	Primary Pharmaceuticals, Inc.	ANDA	Current
72275-705	Zenevix	Lidocaine Patch, Sublingual Tincture	Primary Pharmaceuticals, Inc.	ANDA	Current
72275-732	Dermalid	Lidocaine Patch	Primary Pharmaceuticals, Inc.	ANDA	Current
72835-501	LMR Plus	Lidocaine	V2 Pharma, LLC	ANDA	Current
72835-501	LMR Plus	Lidocaine	V2 Pharma, LLC	ANDA	Current
72835-501	LMR Plus	Lidocaine	V2 Pharma, LLC	ANDA	Current
72835-501	LMR Plus	Lidocaine	V2 Pharma, LLC	ANDA	Current
76420-037	Lidocaine	Lidocaine	Asclemed USA, Inc.	ANDA	Current
76420-037	Lidocaine	Lidocaine	Asclemed USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22834	ORIG	2012-10-09
9840	ORIG	2012-08-28