Application 080409

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LTA II 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
A080409-001	LTA II KIT	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / 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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080409-001	LTA II KIT	4%	SOLUTION / TOPICAL	Approved before 1982	`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 5 of 15 · 300 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	42d9e4cf-ca73-ec6d-e063-6394a90ae937	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	3f2bdb1f-f1c0-370d-e063-6294a90a5c50	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	46404c7b-2ea4-e47b-e063-6294a90a779f	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	4643042c-ec95-3bad-e063-6294a90a8250	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cardinal Health 107, LLC	4e46cac7-00cd-4a01-ba11-9af4960cfbe9	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Gold Bond Medicated Pain and Itch Relief	LIDOCAINE HYDROCHLORIDE	Gold Bond Co LLC	d240e9b8-3506-42ab-8a50-05e8d3fac4ff	2025-12-04	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
POMG NIGHT TIME PAIN RELIEF ROLLER	LIDOCAINE HYDROCHLORIDE	POMG LLC	28d7dfb0-a94c-90de-e063-6294a90a036a	2025-12-02	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Brookfield Pharmaceuticals, LLC.	e824ba5b-3289-5ad4-e053-2995a90acc20	2025-11-27	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Walgreen Pain Relieving Fragrance Free	LIDOCAINE HYDROCHLORIDE	WALGREENS CO.	62c50ded-3fc9-4f65-9bfb-1144ed2e36b4	2025-11-26	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	82b377ee-0e3e-4cb9-a644-f45434c21cca	2025-11-26	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	ProPharma Distribution	42df73b0-20ee-d1aa-e063-6294a90aa275	2025-11-21	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Dextrum Laboratories, Inc	441daa6f-f273-ac09-e063-6394a90a252c	2025-11-21	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	313a7e1f-c1a9-4fa5-bb83-7256c271b351	2025-11-17	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	335dfa50-56f3-4c02-b713-8eef4e28eb45	2025-11-17	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Launch Medical	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	293ef514-44c1-43ac-9a81-c30e34ad39e5	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Tattoo Numbing Cream Co	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	2a64b3ef-ed2d-49db-996d-f63ffecb5a1e	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Painless Tattoo Numbing	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	efd3289f-dfb2-487c-a76f-00fe8af414e3	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Now Numb Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	fed833f5-4f76-46e8-8ae1-655a9e576f70	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Painless Tattoo Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	852504ec-d4fa-4cae-ba89-7ffb57df8efe	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Arte Maximum strength Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	e612a256-3f44-46db-bb6a-e550c2216fdc	2025-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Application 080409

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#