Application 088802

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE VISCOUS	LIDOCAINE HYDROCHLORIDE	SOLUTION;ORAL	2%	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
A088802-001	LIDOCAINE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1985-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088802-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088802-001	LIDOCAINE VISCOUS	2%	SOLUTION / ORAL	AT	1985-04-26	`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	A088802-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088802-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088802-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088802-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088802-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088802-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088802-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088802-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088802-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088802-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088802-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088802-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088802-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088802-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088802-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088802-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088802-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088802-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088802-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088802-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088802-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088802-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088802-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088802-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088802-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088802-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088802-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088802-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088802-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088802-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088802-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088802-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088802-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088802-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088802-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088802-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088802-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088802-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088802-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088802-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	REMEDYREPACK INC.	6f8d20d2-6a91-4a5b-bfe8-f1baada38442	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088802 application number: ANDA088802
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	79b42076-359d-4258-b1d8-f40e67ac5424	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088802 application number: ANDA088802 ndc (product): 0054-3500
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0050d05a-b8e9-c544-e063-6294a90a0243	2024-02-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088802 application number: ANDA088802
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	75f2d450-aa2e-4a09-b4f7-4fcbcbf8b205	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088802 application number: ANDA088802 ndc (product): 50090-6186

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-3500	Lidocaine Viscous	Lidocaine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3500	Lidocaine Viscous	Lidocaine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0121-0903	Lidocaine Viscous	Lidocaine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0903	Lidocaine Viscous	Lidocaine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
50090-6186	Lidocaine Viscous	Lidocaine Hydrochloride	A-S Medication Solutions	ANDA	Current
55154-5789	Lidocaine Viscous	Lidocaine Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-5789	Lidocaine Viscous	Lidocaine Hydrochloride	Cardinal Health	ANDA	Current
55700-632	Lidocaine Viscous	Lidocaine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-140	LIDOCAINE VISCOUS	LIDOCAINE VISCOUS	Direct RX	ANDA	Current
61919-140	LIDOCAINE VISCOUS	LIDOCAINE VISCOUS	Direct RX	ANDA	Current