Application 088389

Type: ANDA
Sponsor: DEPROCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIGNOSPAN FORTE	EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 0.02MG BASE/ML;2%	No	Yes

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
A088389-001	LIGNOSPAN FORTE	EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION		RLD, RS	1985-01-22

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Benco Dental	9419ac39-9b26-4cca-a2d6-167205fede24	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389 ndc (product): 66975-415
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Darby Dental Supply, LLC	27e8fdfb-e923-4f99-aff7-8b9e50228151	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389 ndc (product): 66467-9710
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Patterson Dental	f074c0dc-7c3f-46fd-a480-b8337a19fe5c	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389 ndc (product): 50227-1020
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Henry Schein Inc.	1ca96c77-d983-496b-84a6-54709e80f532	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389 ndc (product): 0404-6500
Lignospan Forte	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	f8ca7d03-01c8-450f-9279-59789c3497ea	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389 ndc (product): 0362-1096
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Dentsply Pharmaceutical	14b55cf9-f7cd-4bb4-a7c5-aba61abadef1	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389 ndc (product): 66312-181
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	df130310-41db-45df-a214-9da01cf0bf41	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389 ndc (product): 0362-0262

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0362-0262	Lidocaine	Lidocaine Hydrochloride and Epinephrine	Septodont, Inc.	ANDA	Current
0362-0262	Lidocaine	Lidocaine Hydrochloride and Epinephrine	Septodont, Inc.	ANDA	Current
0362-1096	Lignospan Forte	Lidocaine Hydrochloride and Epinephrine	Septodont, Inc.	ANDA	Current
0362-1096	Lignospan Forte	Lidocaine Hydrochloride and Epinephrine	Septodont, Inc.	ANDA	Current
0362-1096	Lignospan Forte	Lidocaine Hydrochloride and Epinephrine	Septodont, Inc.	ANDA	Current
0362-1096	Lignospan Forte	Lidocaine Hydrochloride and Epinephrine	Septodont, Inc.	ANDA	Current
0362-9010	Octocaine 50	Lidocaine Hydrochloride and Epinephrine Bitartrate	Septodont	ANDA	Current
0404-6500	LIDOCAINE	Lidocaine Hydrochloride and Epinephrine Bitartrate	Henry Schein Inc.	ANDA	Current
0404-6500	LIDOCAINE	Lidocaine Hydrochloride and Epinephrine Bitartrate	Henry Schein Inc.	ANDA	Current
31382-262	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	CareStream Health, Inc.	ANDA	Current
50227-1020	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Patterson Dental	ANDA	Current
50227-1020	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Patterson Dental	ANDA	Current
51004-0550	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Novocol Pharmaceutical of Canada, Inc.	ANDA	Current
51004-1096	Lignospan Forte	Lidocaine Hydrochloride and Epinephrine Bitartrate	Novocol Pharmaceutical of Canada, Inc.	ANDA	Current
66312-181	Xylocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Dentsply Pharmaceutical	ANDA	Current
66312-181	Xylocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Dentsply Pharmaceutical	ANDA	Current
66312-181	Xylocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Dentsply Pharmaceutical	ANDA	Current
66467-9710	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Darby Dental Supply, LLC	ANDA	Current
66467-9710	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Darby Dental Supply, LLC	ANDA	Current
66975-415	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Benco Dental	ANDA	Current
66975-415	Lidocaine	Lidocaine Hydrochloride and Epinephrine Bitartrate	Benco Dental	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83017	SUPPL	2025-08-01
83014	SUPPL	2025-08-01