Application 207962

Type: NDA
Sponsor: SCILEX PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZTLIDO	LIDOCAINE	PATCH;TOPICAL	1.8%	Yes	Yes

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
N207962-001	ZTLIDO	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	RLD, RS	2018-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N207962-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207962-001	10765640	2031-05-10		Drug product	2020-10-06
N207962-001	10765749	2031-05-10		Drug product	2020-10-06
N207962-001	11278623	2031-05-10		Drug product	2022-04-01
N207962-001	11786455	2031-05-10	U-2267	Drug product	2023-10-23
N207962-001	11793766	2031-05-10	U-2267		2023-11-06
N207962-001	9283174	2031-05-10		Drug product	2018-03-12
N207962-001	9925264	2031-05-10	U-2267	Drug product	2018-04-25
N207962-001	9931403	2031-05-10		Drug product	2018-04-25

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL	AB	RLD, RS	2018-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL	AB	RLD, RS	2018-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL	AB	RLD, RS	2018-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207962-001	ZTLIDO	1.8%	PATCH / TOPICAL		RLD, RS	2018-02-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207962-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207962-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207962-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 265 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207962-001	10765640	2031-05-10		Drug product	2020-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207962-001	10765749	2031-05-10		Drug product	2020-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207962-001	11278623	2031-05-10		Drug product	2022-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207962-001	11786455	2031-05-10	U-2267	Drug product	2023-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207962-001	11793766	2031-05-10	U-2267		2023-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207962-001	9283174	2031-05-10		Drug product	2018-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207962-001	9925264	2031-05-10	U-2267	Drug product	2018-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207962-001	9931403	2031-05-10		Drug product	2018-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	10765640	2031-05-10		Drug product	2020-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	10765749	2031-05-10		Drug product	2020-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	11278623	2031-05-10		Drug product	2022-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	11786455	2031-05-10	U-2267	Drug product	2023-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	11793766	2031-05-10	U-2267		2023-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	9283174	2031-05-10		Drug product	2018-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	9925264	2031-05-10	U-2267	Drug product	2018-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207962-001	9931403	2031-05-10		Drug product	2018-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207962-001	10765640	2031-05-10		Drug product	2020-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207962-001	10765749	2031-05-10		Drug product	2020-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207962-001	11278623	2031-05-10		Drug product	2022-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207962-001	11786455	2031-05-10	U-2267	Drug product	2023-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207962-001	11793766	2031-05-10	U-2267		2023-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207962-001	9283174	2031-05-10		Drug product	2018-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207962-001	9925264	2031-05-10	U-2267	Drug product	2018-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207962-001	9931403	2031-05-10		Drug product	2018-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207962-001	10765640	2031-05-10		Drug product	2020-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207962-001	10765749	2031-05-10		Drug product	2020-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207962-001	11278623	2031-05-10		Drug product	2022-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207962-001	11786455	2031-05-10	U-2267	Drug product	2023-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207962-001	11793766	2031-05-10	U-2267		2023-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207962-001	9283174	2031-05-10		Drug product	2018-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207962-001	9925264	2031-05-10	U-2267	Drug product	2018-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207962-001	9931403	2031-05-10		Drug product	2018-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207962-001	10765640	2031-05-10		Drug product	2020-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207962-001	10765749	2031-05-10		Drug product	2020-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207962-001	11278623	2031-05-10		Drug product	2022-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207962-001	11786455	2031-05-10	U-2267	Drug product	2023-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207962-001	11793766	2031-05-10	U-2267		2023-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207962-001	9283174	2031-05-10		Drug product	2018-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207962-001	9925264	2031-05-10	U-2267	Drug product	2018-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207962-001	9931403	2031-05-10		Drug product	2018-04-25	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N207962-001	NP	2021-02-28	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N207962-001	NP	2021-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207962-001	NP	2021-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207962-001	NP	2021-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207962-001	NP	2021-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207962-001	NP	2021-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207962-001	NP	2021-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207962-001	NP	2021-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207962-001	NP	2021-02-28	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ztlido	LIDOCAINE	Scilex Pharmaceuticals Inc.	a1b17507-4560-490d-a388-74e7fd7eaa5e	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207962 application number: NDA207962 ndc (product): 69557-111

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
69557-111	Ztlido	Lidocaine	Scilex Pharmaceuticals Inc.	NDA	Current
69557-111	Ztlido	Lidocaine	Scilex Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67023	SUPPL	2021-04-12
67010	SUPPL	2021-04-09
59390	ORIG	2019-07-22
56574	SUPPL	2018-11-27
56405	SUPPL	2018-11-09
53016	ORIG	2018-03-15
52797	ORIG	2018-03-02