Application 203265

Type: ANDA
Sponsor: NOVEN PHARMS 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 43.

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
A203265-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL			2020-12-01

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-12-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-12-01	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203265-001	LIDOCAINE	5%	PATCH / TOPICAL		2020-12-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203265-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203265-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203265-001	AB	1	`8869cabd3fbd…`

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 9 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Numbing Cream	LIDOCAINE	Sainite Trading Shenzhen Co., Ltd.	49fcbe81-34b6-5906-e063-6294a90aa65b	2026-02-04	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	PHOENIX RX LLC	40949067-a5a8-db8c-e063-6294a90af0fb	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
PAIN RELIEF PATCHES	LIDOCAINE	WALMART STORES INC	b82cfe42-f521-4784-8c60-98481524c5ec	2026-01-29	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Fougera Pharmaceuticals, LLC	88ca9cba-0c4a-482f-b502-ceefdb1bfbcd	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine Pain Relief	LIDOCAINE	Trifecta Pharmaceuticals USA, LLC.	493c09d0-16d7-7413-e063-6394a90aa052	2026-01-26	Warnings	Name fallback generic name: LIDOCAINE
CVS 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct Large	LIDOCAINE	CVS PHARMACY, INC	4914965f-1164-e20e-e063-6294a90ac221	2026-01-23	Warnings	Name fallback generic name: LIDOCAINE
Equate Pain Relieving Cream Lidocaine	LIDOCAINE	Wal-Mart Stores Inc	52b91508-22aa-4c4b-94f4-977f14a01dad	2026-01-20	Warnings	Name fallback generic name: LIDOCAINE
Black Cobra Tattoo NumbingSpray 4% Lidocaine	LIDOCAINE	Foshan Sugar Max Cosmetics CO.,Ltd	3605fcbf-63c8-87b5-e063-6294a90a9c3e	2026-01-19	Warnings	Name fallback generic name: LIDOCAINE
Black Cobra Tattoo Numbing Cream 4% Lidocaine	LIDOCAINE	Foshan Sugar Max Cosmetics CO.,Ltd	3605961a-d596-9c4a-e063-6394a90a99dc	2026-01-19	Warnings	Name fallback generic name: LIDOCAINE
DYNAMO DELAY SAMPLE BOTTLE	LIDOCAINE	Momentum Management LLC	05370186-1b82-4d0f-9382-b153252c0221	2026-01-19	Warnings	Name fallback generic name: LIDOCAINE
Aspercreme with Lidocaine	LIDOCAINE	Chattem, Inc.	7ad8efa9-7031-4cd0-be1d-6dee63091fd1	2026-01-19	Warnings	Name fallback generic name: LIDOCAINE
TOPCARE PAIN RELIEF PATCHES	LIDOCAINE	TOPCO ASSOCIATES, LLC	fa2f7768-e779-4409-aad3-6c33ce2e6b36	2026-01-18	Warnings	Name fallback generic name: LIDOCAINE
Aspercreme with Lidocaine XL	LIDOCAINE	Chattem, Inc.	b0859b10-539e-4905-ab52-af78b778d6a4	2026-01-15	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Patch	LIDOCAINE	FlexiGo Inc.	4868af2a-c4be-9c68-e063-6394a90a565b	2026-01-15	Warnings	Name fallback generic name: LIDOCAINE
Careland Lidocaine 4 Pain Relieving Gel-Patches	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	a6ca8382-7ce5-4df9-912e-8a0ac0423116	2026-01-15	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE 4%	AvKARE	70aace2f-47b4-e961-e053-2991aa0a6367	2026-01-14	Warnings	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE	AvKARE	0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Aspercreme with Lidocaine Essential Oils Rosemary Mint	LIDOCAINE	Chattem, Inc.	9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab	2026-01-13	Warnings	Name fallback generic name: LIDOCAINE
THE SOLUTION 2.0	LIDOCAINE	SCALP TECH INC	0fa423b6-cc0f-b569-e063-6294a90a239e	2026-01-09	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bellus Medical, LLC	60cb89f6-e326-0773-e053-2a91aa0a33dd	2026-01-09	Warnings	Name fallback brand name: Lidocaine generic name: LIDOCAINE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66993-342	Lidocaine Patch, 5%	Lidocaine	Prasco Laboratories	ANDA	Current