Application 208822

Type: ANDA
Sponsor: VITRUVIAS THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE	LIDOCAINE	OINTMENT;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
A208822-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL			2017-09-25

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 · 43 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
2026-09-14 22:38:34	2026-08	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2017-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208822-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2017-09-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208822-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208822-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208822-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208822-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208822-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208822-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208822-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208822-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208822-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208822-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208822-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208822-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208822-001	AT	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208822-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208822-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208822-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208822-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208822-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208822-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208822-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208822-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208822-001	AT	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 25 of 26 · 504 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactine Max Antibiotic and Lidocaine Max Pain Relief	LIDOCAINE	WellSpring Pharmaceutical Corporation	71300df9-6113-4f25-93ca-28ad7e7f79de	2023-06-08	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Proficient Rx LP	2b9150ea-a876-4511-8d5b-aa72507ef863	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86083fea-c064-4ef7-e053-2a91aa0ac17c	2023-05-16	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86093c75-6dde-bb16-e053-2991aa0ab6ef	2023-05-16	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Bactine Max Lidocaine Roll-on 2.5oz	LIDOCAINE	WellSpring Pharmaceutical Corporation	09b32a98-9131-451e-87a6-81a1e4ed7ec5	2023-04-25	Warnings	Name fallback generic name: LIDOCAINE
lidocaine	LIDOCAINE	Asclemed USA, Inc.	58c9afe4-dc36-4f71-8e76-8dff63dc35fb	2023-03-27	Warnings, Adverse reactions	Name fallback brand name: lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	a134c265-4fb6-4c78-b9cc-fae8f1fff1cf	2023-03-15	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	68bc320f-2871-45b9-815e-bb26081e8249	2023-03-02	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	da9707e2-f830-45e2-a300-1f99cf3dd362	2023-02-20	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	QUAGEN PHARMACEUTICALS LLC	f8789807-cc0c-485c-aa98-1bdc39337deb	2023-02-15	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
lidocaine	LIDOCAINE	Proficient Rx LP	8a85ea77-91ad-4222-9bfe-2ffaf73182e8	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	80dadfb5-cbe6-475f-9980-a1b255982753	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
lidocaine	LIDOCAINE	Proficient Rx LP	f9b290d2-0e24-4ca8-bca2-3016f5c404df	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	4d04052c-3e0a-469a-9265-99604f13e507	2022-04-30	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Proficient Rx LP	2c396307-cf12-41d0-89e6-0f4ec74df55e	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
lidocaine	LIDOCAINE	Asclemed USA, Inc.	6abf3773-0e60-48b1-9d5c-adc590363d13	2021-08-09	Warnings, Adverse reactions	Name fallback brand name: lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Proficient Rx LP	f1007717-528a-42e2-94aa-db0edf3bb603	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidoxryl	LIDOCAINE	PureTek Corporation	1c33790b-8d57-46e8-bd6e-5a0f87a3c29f	2020-11-10	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
LidoPure Patch	LIDOCAINE	PureTek Corporation	c851c6e9-1966-4639-9406-fe6adc91c9d0	2020-11-10	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	c18f0c2b-cd05-4458-888f-47b4a1106937	2020-11-03	Warnings, Adverse reactions	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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69680-120	LIDOCAINE	LIDOCAINE	VITRUVIAS THERAPEUTICS	ANDA	Current
69680-120	LIDOCAINE	LIDOCAINE	VITRUVIAS THERAPEUTICS	ANDA	Current
69680-120	LIDOCAINE	LIDOCAINE	VITRUVIAS THERAPEUTICS	ANDA	Current
69680-120	LIDOCAINE	LIDOCAINE	VITRUVIAS THERAPEUTICS	ANDA	Current