Application 214269

Type: ANDA
Sponsor: SINTETICA SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	4%	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
A214269-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP		2022-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214269-001	AP

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	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214269-001	LIDOCAINE HYDROCHLORIDE	4%	INJECTABLE / INJECTION	AP	2022-05-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214269-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214269-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214269-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214269-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214269-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214269-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214269-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214269-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214269-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214269-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214269-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214269-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214269-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214269-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214269-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214269-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214269-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214269-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214269-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214269-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214269-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214269-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214269-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214269-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214269-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214269-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214269-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214269-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214269-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214269-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214269-001	AP	1	`a50c72e98297…`

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 16 · 307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XeroBurn Burn Gel	LIDOCAINE HYDROCHLORIDE	Dynarex Corporation	58985046-ca9c-12be-e053-2991aa0abe72	2025-03-13	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Novagenix Labs LLC	7567ffb5-953a-4be9-9a02-c5a50dcd9306	2025-03-12	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	ARMAS PHARMACEUTICALS INC.	2f6e0f3d-ceaf-a853-e063-6394a90a8efb	2025-03-07	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lightning Products BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	555ac696-e761-4a5a-bed8-945dc64d5be5	2025-02-27	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	f1b26274-a55e-4321-b96c-ce0df830f205	2025-02-20	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	McKesson Corporation dba SKY Packaging	e1eabd6b-9bb8-646f-e053-2a95a90a7b83	2025-02-20	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	NorthStar RxLLC	6a7fa6c5-b550-46ac-99a3-5c49339e6dbd	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	9916b09d-a116-469d-92d5-60e50ea9782b	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
TheraCare Pain Relieving Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	2d42192b-8889-a896-e063-6294a90a4fc8	2025-02-03	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	ccc38d8a-43fd-44c0-985e-32af9ed956ab	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	d5e23ede-957c-4a32-b1c6-268acb773c31	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
INTIMALE LIDOCAINE DELAY	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	5ddd7d56-bf51-462b-afcd-944861e49781	2025-01-28	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Meijer Odor Free Analgesic Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	6288efea-f636-4eea-bb9f-78aa2f9af54a	2025-01-14	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
IKONIK TONIK	LIDOCAINE HYDROCHLORIDE	IKONIK CARE, LLC	122fdfe8-b5fa-46d1-9fd9-3df9887ed320	2025-01-14	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Burn Jel	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	ff621b46-2342-41db-994d-851a09796d08	2025-01-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4c19cf5-c8b1-5e9f-e053-2995a90aee53	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
HealthWise 4% Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	0fb2af30-7f2d-c7c4-e063-6294a90a37f7	2024-12-19	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	79b42076-359d-4258-b1d8-f40e67ac5424	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Serum X	LIDOCAINE HYDROCHLORIDE	AO Biologix, LLC	e07b6268-6400-6849-e053-2a95a90a8b3e	2024-12-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	McKesson Corporation dba SKY Packaging	903cd7bd-6c3d-4068-bb24-e91b1ca1393d	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68055-649	NA	Lidocaine Hydrochloride	SINTETICA SA	ANDA	Current
68055-649	NA	Lidocaine Hydrochloride	SINTETICA SA	ANDA	Current
83090-007	NA	Lidocaine Hydrochloride	Sintetica US LLC	ANDA	Current