Application 080429

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANESTACON	LIDOCAINE HYDROCHLORIDE	JELLY;TOPICAL	2%	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
A080429-001	ANESTACON	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080429-001	ANESTACON	2%	JELLY / TOPICAL	Approved before 1982	`f41ea6bd6efb…`

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 11 of 16 · 302 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Lifestar Pharma LLC	9cb98fb0-5204-4973-8be7-f44ddbfde2ab	2024-09-03	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Wildman Business Group	1fd1a4b3-b6fd-0d4c-e063-6394a90a3680	2024-09-01	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	0cbc37d3-c2d6-4747-9834-7c23b38fcc20	2024-08-30	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5a41d694-4628-4911-e053-2991aa0a91e5	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Lifestar Pharma LLC	8149138a-4106-4ae6-b7ad-f2559c7fa7e2	2024-08-13	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidotral 5 Percent Roll On Gel	LIDOCAINE HYDROCHLORIDE	Puretek Corporation	1c4c9ce5-f12d-9c47-e063-6294a90a0b3c	2024-08-02	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Fruit of the Earth Aloe Vera Cool Blue	LIDOCAINE HYDROCHLORIDE	Fruit of the Earth, Inc.	1d65bc34-2bc2-4f52-a9b3-1cb08324eb79	2024-07-19	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
CVS Health Sunburn Relief Cooling	LIDOCAINE HYDROCHLORIDE	CVS PHARMACY	1d6402ea-4201-27f9-e063-6294a90a43f5	2024-07-16	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	NorthStar RxLLC	f065e6d2-b47e-433d-a1fb-f0449cd725f1	2024-07-05	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	1b584ef0-3663-0d2a-e063-6394a90a1757	2024-06-20	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	45416533-17a1-4757-b24e-b33d1ee57471	2024-06-20	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidotral Five Percent	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	1a156ffe-1ec9-d2f9-e063-6394a90a3381	2024-06-04	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
THE SOLUTION NUMBING	LIDOCAINE HYDROCHLORIDE	SCALP TECH INC	184be4cc-b0b9-7882-e063-6394a90a8e7e	2024-05-25	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TheraCare 4% Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	c808aa05-9d49-cc9f-e053-2a95a90a50f3	2024-05-21	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SAFLY Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	3aca2568-d10f-4b14-861b-6c741c106829	2024-05-17	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidotral Two Percent	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	185d3e09-4005-b032-e063-6294a90a5efe	2024-05-14	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine MPF	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	d5e0d06f-ba1e-44d4-aa89-39d6c146dc23	2024-05-13	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme with Lidocaine Pain Relieving Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd	2024-05-01	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HCl 4 Percent	LIDOCAINE HYDROCHLORIDE	ARI BRANDS, LLC	81aff5c5-91c0-4173-a432-d20115613580	2024-04-30	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Burn	LIDOCAINE HYDROCHLORIDE	JHK Inc	5a4ac4cc-015a-48e7-81f8-93a895049afd	2024-04-25	Warnings	Name fallback 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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-772	Anestacon	Lidocaine hydrochloride	Hi-Tech Pharmacal Co., Inc.	ANDA	Current