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 4 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0.5% LIDOCAINE BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	cf723c7b-495d-4bae-942c-561cf28af2d3	2026-02-21	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride and Dextrose	LIDOCAINE HYDROCHLORIDE	Baxter Healthcare Corporation	f21512ea-c7c3-4766-b976-b2c0b5616bf0	2026-02-20	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Advagen Pharma Ltd	ae40021b-8df8-4b16-aac0-dcec88f76c7d	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride 2%	LIDOCAINE HYDROCHLORIDE	Aldermed Inc.	4977b722-d08d-3d9e-e063-6294a90a9035	2026-02-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Anthea Pharma Private Limited	240c4744-e58c-4c08-93ad-8d6418c4f8a9	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	89701fac-7536-4f16-87fb-f4cc121e74ee	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
2.0% LIDOCAINE BURN	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	2b58058a-f350-4029-b039-117caf1c0373	2026-02-05	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
glydo	LIDOCAINE HYDROCHLORIDE	Sagent Pharmaceuticals	65760723-75cd-472c-96e1-7d05f95b4686	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	415a29c1-101a-4ac2-9ba9-b419a1ce5600	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	94155012-b1fc-430a-a1f5-30c21f4a3f80	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
5Kind Maximum Strength Pain Relieving Lidocaine HCl Hemp	LIDOCAINE HYDROCHLORIDE	5Kind Trading LTD	c2df4c90-2b9e-460a-8f54-5d824b484163	2026-01-28	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
VonaFlex Effective Pain Relief Topical Analgesic	LIDOCAINE HYDROCHLORIDE	OPTIMAL LABORATORIES, LLC	0901244a-7d41-413a-b424-92a807532f28	2026-01-28	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
ALOE ICE SUNBURN RELIEF	LIDOCAINE HYDROCHLORIDE	Aloe Care International, LLC	56866fa8-052e-497c-a954-978d7d628949	2026-01-28	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Chartwell RX, LLC	c05f49a2-7512-48e7-9730-f8ee05519b9d	2026-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	f79b8b30-67ed-4daa-8233-ee2319592ef0	2026-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	48c18a90-9d53-d200-e063-6394a90a1271	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
CVS Lidocaine Pain Relief Cream	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	45c4f946-13b9-7a0a-e063-6394a90a7353	2026-01-16	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Gold Bond Medicated Pain and Itch Relief	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	5767362c-83af-494e-a815-a13f2cb093ef	2026-01-14	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme Lidocaine Foot (Diabetic)	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	2c33d15e-5032-46d9-bd98-5abc7df3bbe5	2026-01-13	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Avenacy, LLC	46480253-29b9-4d7f-98ed-10377929026b	2026-01-13	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