Application 202346

Type: ANDA
Sponsor: MYLAN TECHNOLOGIES

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
A202346-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL	AB		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
A202346-001	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	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202346-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2015-08-07	`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	A202346-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202346-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202346-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202346-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202346-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202346-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202346-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202346-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202346-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202346-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202346-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202346-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202346-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202346-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202346-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202346-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202346-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202346-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202346-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202346-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202346-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202346-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202346-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202346-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202346-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202346-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202346-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202346-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202346-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202346-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202346-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202346-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202346-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202346-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202346-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202346-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202346-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202346-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202346-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202346-001	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 26 · 510 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Ascend Laboratories, LLC	67a6bbbd-ab4b-414a-b85c-b7d8c0cfa9d2	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	NDC, Inc.	937e9341-e604-4ca7-98e1-fc7c659d82e9	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE
Lidocaine Numbing Cream	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	5457b3d7-e6b6-34a7-e063-6394a90aa240	2026-08-03	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	PHOENIX RX LLC	57edfcb8-272c-8af4-e063-6294a90ae2e5	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Benco Dental	c5cc87df-df3f-42b8-af84-5f2045d42084	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Benco Dental	9419ac39-9b26-4cca-a2d6-167205fede24	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Patterson Dental	6506755f-c9f7-4286-9ba7-ac5d5745f5e4	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Darby Dental Supply, LLC	27e8fdfb-e923-4f99-aff7-8b9e50228151	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Darby Dental Supply, LLC	e5ed4c2a-e320-48cf-a2fd-61d48481c624	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Patterson Dental	f074c0dc-7c3f-46fd-a480-b8337a19fe5c	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	57994923-20fc-9d9d-e063-6394a90a22c9	2026-07-27	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	579a5012-837a-828b-e063-6294a90a4fb2	2026-07-27	Warnings	Name fallback generic name: LIDOCAINE
Lidfix Pain Relief Patch Lidocaine	LIDOCAINE	HETERO HEALTHCARE LIMITED	2149f0e3-1983-4f02-929e-ecd20357f4bb	2026-07-27	Warnings	Name fallback generic name: LIDOCAINE
RectoProtect	LIDOCAINE	Akron Pharma Inc.	1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb	2026-07-27	Warnings	Name fallback generic name: LIDOCAINE
NUMBING	LIDOCAINE	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	578675e8-30e7-6986-e063-6394a90a8afe	2026-07-26	Warnings	Name fallback generic name: LIDOCAINE
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	578fa642-ff30-e511-e063-6294a90a5987	2026-07-26	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief Patch Lidocaine	LIDOCAINE	HyVee	41c26a66-3371-2c2c-e063-6294a90aa38b	2026-07-22	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Shaanxi Shuvita Biotech Co., Ltd	572b95a1-11b2-6328-e063-6394a90acb73	2026-07-21	Warnings	Name fallback brand name: Lidocaine generic name: LIDOCAINE
RectaEase Hemorrhoid Relief Cream	LIDOCAINE	Trifecta Pharmaceuticals USA LLC	c054921a-9f1b-7c75-e053-2995a90a1738	2026-07-20	Warnings	Name fallback generic name: LIDOCAINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-9055	Lidocaine	lidocaine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9055	Lidocaine	lidocaine	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57199	ORIG	2019-01-14