Application 080404

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1%	No	No
003	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 2 · 52 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
2023-05-13 08:27 UTC	2023-05	A080404-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080404-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080404-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080404-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080404-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080404-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080404-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080404-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080404-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A080404-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080404-002	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080404-003	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

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	A080404-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080404-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080404-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080404-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080404-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080404-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080404-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080404-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080404-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080404-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080404-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080404-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080404-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080404-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080404-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080404-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080404-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080404-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080404-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080404-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080404-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080404-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080404-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080404-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080404-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080404-003	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080404-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080404-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080404-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080404-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080404-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080404-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080404-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080404-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080404-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080404-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080404-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080404-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080404-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080404-003	AP	1	`3f0d92c62455…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	cddb2b22-fce3-8967-6e54-dca3df5ac4b3	2025-03-26	Warnings, Adverse reactions	Exact identifier ndc (product): 63323-202 ndc (product): 63323-201

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61699-0201	Lidocaine	LIDOCAINE HYDROCHLORIDE	US MedSource, LLC	ANDA	Current
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-201	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-202	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-202	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-202	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-202	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-202	Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
70518-2651	Lidocaine	LIDOCAINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2651	Lidocaine	LIDOCAINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current