Application 086364

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LARYNG-O-JET KIT	LIDOCAINE HYDROCHLORIDE	SOLUTION;TOPICAL	4%	No	No

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
A086364-001	LARYNG-O-JET KIT	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086364-001	AT

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086364-001	LARYNG-O-JET KIT	4%	SOLUTION / TOPICAL	AT	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086364-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086364-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086364-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086364-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086364-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086364-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086364-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086364-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086364-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086364-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086364-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086364-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086364-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086364-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086364-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086364-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086364-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086364-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086364-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086364-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086364-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086364-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086364-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086364-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086364-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086364-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086364-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086364-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086364-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086364-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086364-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086364-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086364-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086364-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086364-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086364-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086364-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086364-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086364-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086364-001	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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOCAINE HCl	LIDOCAINE HCL	HF Acquisition Co LLC, DBA HealthFirst	c4c16714-6b1f-857e-e053-2a95a90a74e4	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086364 application number: ANDA086364 ndc (product): 51662-1553
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	2c48cfac-81eb-4a81-8590-bc94574dd4c3	2021-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086364 application number: ANDA086364 ndc (product): 76329-6300

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4557	Lidocaine Hydrochloride	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
51662-1553	LIDOCAINE HCl	LIDOCAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1553	LIDOCAINE HCl	LIDOCAINE HCl	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
76329-6300	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current
76329-6300	Lidocaine Hydrochloride	Lidocaine Hydrochloride	International Medication Systems, Limited	ANDA	Current